PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Device Registration & Listing · BEST Noord-Brabant, NL · Registration 3042177665

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042177665
FEI Number
3042177665
Entity Name
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
City/State/Country
BEST Noord-Brabant, NL
Establishment Address
VEENPLUIS 6, BEST Noord-Brabant 5684 PC, NL
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Philips Medical Systems International BV (Owner Number: 1217116)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Ingenia Ambition X Ingenia Ambition S Philips SENSE NV Coil 3T 8Ch SENSE NV Coil 3T/8ch Ingenia 3T CX R5.4 Ingenia 1.5T Ingenia 1.5T CX Ingenia 3T Ingenia 1.5T S MR 5300 Smart Fit TorsoCardiac 1.5T Siemens SYMPHONY SMALL EXTREMITY ARRAY dS Small Extremity 16Ch 1.5T Coil dS Small Extremity 16ch 3T dS Small Extremity 16Ch 3T Philips Array Coil Interface Box Toshiba 1.5T GP Flex Coil 528GE Series Synergy Shoulder Coil Philips MRCAT RTgo Airis Elite Rapid Extremity Coil Signa 1.5T 4Ch Shoulder Coil GE Signa 1.5T 4Ch Shoulder Coil Toshiba 1.5T 4Ch Shoulder Coil GE 1.5T 4Ch Shoulder Coil Phased Array Shoulder Coil Shoulder Array Coil GE 0.35T MFO PA WRIST Wrist Array Coil GE 1T SIGNA 4C PA WRIST (OEM) Lateral Array Coil Right VG STR VG BRST TABLE 1.5T 16CH GE450 FULSET GRD SENTINELLE BREAST MRI 8CH Tabletop 3T VS BRST 3T 4CH TT BIOPSY SET w PACKAGING Medial Plug VG STR Medial Single Loop Coil Left VG STR Vanguard Breast MRI Auxiliary Table with 16 Channel Coil Array for GE 3T MRI System Model 4000451-51 Interface Box VG GE750 Lateral Single Loop Coil Left VGTT Medial Array Coil VG GE450 Lateral Single Loop Coil Right VG GE450 Medial Array Coil VGTT Single Loop Coil Right VT Lateral Array Coil Right VG GE450 Lateral Single Loop Coil Right VG GE750 Medial Plug VGTT Lateral Array Coil Left VGTT Lateral Single Loop Coil Left VG GE450 Cable Tray VG GE450 Medial Plug VG GE450 Lateral Array Coil Right VG GE750 Lateral Array Coil Right VGTT Lateral Array Coil Right VT Interface Box VT Lateral Single Loop Coil Left VG GE750 Interface Box VGTT 8Ch Lateral Single Loop Coil Right VGTT Lateral Array Coil Left VG GE450 Medial Array Coil VT Lateral Array Coil Left VT Lateral Array Coil Left VG GE750 Single Loop Coil Left VT Medial Array Coil VG GE750 Medial Plug VT Vanguard Breast MRI Table Medial Plug VG GE750 Medial Single Loop Coil Right VG STR SENTINELLE BREAST MRI 8CH Table for GE 3T VT1.5T 8CH TT TITAN FULL SET w GRID Medial Array Coil VS 8Ch SENTINELLE BREAST MRI 16CH Tabletop for GE 3T VS BRST 1.5T 8CH TT FUL SET w SHALOW RSR Sentinelle Breast MRI 8CH Tabletop for Siemens 1.5T Lateral Array Coil Right VS 8Ch Coil Medial Array VT 3T Vanguard Atlas/Titan VS BRST 3T 8CH TT FULL SET w ESPREE RSR VS BRST 1.5T 8CH TT FUL SET w ESPREE RSR Lateral Single Loop Coil Right VG STR Coil Lateral 8CH Array Left VT 3T Lateral Single Loop Coil Left VG STR Medial Array Coil VG STR Sentinelle Breast MRI 8CH Tabletop 1.5T Lateral Array Coil Left VG STR Lateral Array Coil Right Vanguard Breast MRI Tabletop Coil Medial Array Coil VS Sentinelle Breast MRI 8CH Table for GE 1.5T SENTINELLE BREAST MRI 8CH Tabletop for SIEMENS 3T VS BRST 3T 8CH TT FULL SET w SHALLOW RSR Lateral Array Coil VS BRST 3T TT UPGRADE BIOPSY SET w PACKG VS BRST 3T 8CH TT FULL SET w TIM4G RSR SENTINELLE BREAST MRI 16CH Table for GE 1.5T Cable Tray HYP VG ST VS BRST 1.5T 8CH TT FULL SET w TIM4G RSR Lateral Array Coil Left VS 8Ch VG BREAST 1.5T 16CH GE450 FUL SET w GRID Lateral Array Coil Left VS BREAST 3T 8CH TT FULL SET w PACKAGING Ingenia 1.5T Ingenia 1.5T S Ingenia Ambition X Ingenia 3T CX Ingenia Elition X Ingenia 3T Ingenia 1.5T CX Ingenia Ambition S Ingenia Elition S MR-RT CouchTop MRCAT Head & Neck/RTgo 5 RT couchTop XD SYN.BODY COIL 1.5T ODU 4598-005-5189x SENSE FLEX S COIL 1.5T ODU 4522-133-1719x T/R Head Coil 1.5T (QHC 1H T/R ACS-NT-L) 4598-002-0529x QUAD HEAD COIL 1.5T 4522-133-1727x SENSE FLEX L COIL 1.5T ODU 4522-133-1715x MRI COILS SYN.BODY COIL 1.5T WITH SLEEVE 4598-000-5187x SENSE SPINE COIL 1.5T ODU 4522-133-1724x SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-009-6978x SENSE CARDIAC COIL 4522-133-1726x SENSE FLEX M COIL 1.5T ODU 4522-133-1717x SENSE SPINE COIL 1.5T 4522-133-1723x SHNC DRIVERBOX 1.5T 4598-000-5181x SHNC DRIVERBOX 1.5T ODU 4598-000-5182x Achieva 1.5T family Intera 1.5T family SENSE FLEX S COIL 1.5T 4522-133-1718x CIRC.COIL C3 1.5T 4598-000-5196x MICRO 23MM COIL 4598-000-5197x MICRO 47MM COIL 4598-000-5198x ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x POSTERIOR - SYN HEAD/NECK COIL 4598-000-5193x CIRC.COIL C1 1.5T 4598-000-5184x SENSE CARDIAC COIL 4522-133-1725x SENSE FLEX M COIL 1.5T 4522-133-1716x SENSE FLEX L COIL 1.5T 4522-133-1714x Philips SENSE NV Coil, 1.5T 8Ch, Philips 1.5T Intera 16ch SENSE NV Array SENSE NV Coil 1.5T/8ch SENSE NV Coil 1.5T/16ch dS Knee Coil 8ch 1.5T dS Breast Coil 7ch 1.5T Philips 4-ch SENSE Wrist Coil 3T 4-ch SENSE Wrist Coil 1.5T INTERA 1.5T High Res Wrist Coil PA, Philips 4-ch SENSE Wrist Coil 1.5T OBC-250-PAN BREAST ARRAY COIL 0.6T Panorama 4Ch Breast Array ST SENSE Breast Coil dS FootAnkle 16 CH 1.5T dS HiRes Hand/Wrist 16Ch 1.5T dS FootAnkle 16 CH 3T dS Small Extremity 16CH 3T dS HiRes Hand/Wrist 16Ch 3T dS Small Extremity 16Ch 1.5T dS FootAnkle 16CH 3T dS Small Extremity 16Ch 3T dS FootAnkle 16CH 1.5T dS FootAnkle 16Ch 3T INTERA 1.5T Shoulder Coil Set 4Ch PA, Philips 4-ch SENSE Shoulder Coil 1.5T Ingenia Elition and MR 7700 MR Systems Altaire Rapid Head Coil Airis Elite Rapid Head Coil Ingenia Elition MR 7700 with Distributed Multi Nuclei Ingenia 3T Ingenia 3TCX 32 Ch Head dS Head 32ch 3T Achieva 1.5T, 3T, and Intera 1.5T Sense head coil 3T Sense NV Coil 3T OBC-300 Breast Array Coil Philips SENSE Wrist Coil 1.5T 8Ch GE Excite HD 1.5T 8 Channel Wrist (PRECISION EIGHT WRIST ARRAY) Siemens AVANTO/ESPREE 1.5T 8CH HRW ARRAY Siemens Symphony 1.5T 8Ch HRW Array GE Excite HDx PRECISION EIGHT WRIST ARRAY (8CH 1.5T) 8 Channel Wrist MR Coil Kit 1.5T Siemens TrioPrecision Eight Wrist Array (3T) GE, 3T 8CH WRIST COIL dS WRIST 8CH 3T GE 1.5T HDMR2-VALUE 8C WRIST Siemens TRIO/TIM 3T 8CH HRW ARRAY Philips dS 3T 8-ch Wrist Coil Philips dS 1.5T 8-ch Wrist Coil Siemens 1.5T 8Ch Avanto/Espree Precision Eight Wrist Array Philips SENSE Wrist Coil 3T 8Ch GE 1.5T 8CH WRIST COIL Siemens SYMPHONY 1.5T 8CH HRW ARRAY HRW-63-8 GE 3T SIGNA EXCITE 8C WRIST HRW-127-8 WRIST ARRAY COIL GE Excite HDx 3T Hi Res Wrist Array Coil PRECISION EIGHT WRIST ARRAY 8 Channel Wrist MR Coil Kit 3T dS Wrist 1.5T Symphony HR Wrist Array Coil 1.5T 8ch Wrist Array 8 Channel Wrist Coil HD 8Ch Wrist Array HD 8Ch WRIST ARRAY (Receive Only) 8 CHANNEL WRIST COIL 1.5T 8 CHANNEL WRIST COIL 3T dS Wrist 8CH 1.5T SENSE Wrist Coil 3T 8Ch SENSE Wrist Coil 1.5T 8Ch SIEMENS SYMPHONY HIGH RESOLUTION WRIST ARRAY Achieva, Intera,&Panaroma 1T R2 1.5T Musculoskeletal Array 1.5T Array Upper Extremity (MSK Coil) GE Excite HDx 1.5T 3Ch PHASED ARRAY UPPER EXTREMI GE Excite HD 1.5T 4 Channel Musculoskeletal Array Explorer gradients for Gyroscan Intera 1.5T MODELS EXL AND EXS EXTREMITY COIL SET Synergy Head/Neck Coil SmartPath to dStream for XR and 3T Upgrades dStream to R5.7 MR 5300 Ingenia Elition S Ingenia Elition X SmartPath to Ingenia Elition X Upgrades Achieva/Intera to R5.7 Evolution Upgrade 1.5T Ingenia Ambition S SmartPath to dStream for 1.5T Ingenia Ambition X Ingenia 3T Evolution Upgrade 3T PHILIPS 1.5T INTERA (BDAS) 6C KNEE ARRAY, Philips dS Knee 8ch 3T, Philips dS Knee 8ch 1.5T Philips 1.5TSENSE Intera High Res Knee Array Sense Knee Coil 1.5T SENSE Knee Coil 3T/8CH dS Knee Coil 1.5T/8ch SENSE Knee Coil 1.5T/8CH Toshiba 1.5T Knee SPEEDER, Philips SENSE Knee Coil 3T 8Ch, Phililps 6-ch SENSE Knee Coil 3T dS Wrist Coil 8ch 1.5T ds Wrist Coil 8ch 1.5T, Dlisting D551129 MRCAT Pelvis / RTgo 3 SENSE MSK S 8ch 1.5T Ingenia 1.5T Ingenia 3T Ingenia CX 3T Achieva R4 1.5T (Ingenia) Achieva R4 3T (ingenia) Ingenia CX 1.5T wBTS wPPU Sensor Accessories - 98980319363X wBTS Sensor Set, ECG 1 meter - 98980319364X wBTU PPU + RESP Module - 98980319445X wBTU VCG Module - 98980319444X MICROSCOPY COIL SET, INGENIA 3T dS MICROSCOPY 23MM COIL, INGENIA 3T dS MICROSCOPY 47MM COIL, INGENIA 3T dS MICROSCOPY 47MM COIL, INGENIA 1.5T MICROSCOPY COIL SET, INGENIA 1.5T dS MICROSCOPY 23MM COIL, INGENIA 1.5T HITACHI 1.5T 8C TORSO GE 0.7T OPENSPEED HFO 3C WRIST GE 0.7T OPENSPEED (HFO) WRIST MA Extremity Coil, Siemens 1.5T 8-CH HRK COIL dS HeadNeck 3T dS Head 3T dS Head 1.5T dS HeadNeck 1.5T dS Base 3T dS Base 1.5T Intera Family HAC-300 Head Array Coil Philips dS Small Extremity 8ch 3T Philips SENSE Small Extremity 3T 8CH Philips SENSE Small Extremity 1.5T 8Ch Philips dS Small Extremity 8ch 1.5T Extremity Coil 3T Sense Small Extremity 1.5T 8 Small extremity 8ch 3T Small extremity 8ch 1.5T dS SmallExtr 8ch 1.5T SENSE Small Extremity 3T 8 dS SmallExtr 8ch 3T GE 3T VHI 8C HEAD / BRAIN (OEM) GE Excite HDx 8 Channel High Res Head Array (1.5T) GE 3T HDMR2-VALUE 8C HEAD / BRAIN 8 CH HR Brain Array 3 T Brain Array 3T den HD 8Ch HiRes BRAIN array 8Ch High Resolution Brain Array Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems BlueSeal SE BlueSeal XE KFA-63 Knee and Foot Array Philips SENSE Breast Coil 1.5T 4-ch, Philips INTERA 1.5T Breast Coil 4Ch PA SENSE Breast Coil Upgrade to MR 7700 Evolution Upgrade 1.5T SmartPath to MR 7700 SmartPath to Ingenia Elition X BlueSeal XE Ingenia Elition S BlueSeal QE Upgrades dStream to R13 Ingenia Elition X BlueSeal SE MR 7700 Evolution Upgrade 3T MR 5300 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems Trolley Acoustic Hood HA Flex Trak HA FlexTrak II Tabletop Extender FlexTrak MR-OR 3T MR-OR 1.5T GE 1T HNC - OPENVIEW GE 1.5T HNC - OPENVIEW GE 1.5T HDMR2-VALUE 4C NVA COIL VALUE 1.5T GE COMPATIBLE HNC COIL SYS NEUROVASCULAR ARRAY COIL (Receive Only) 7 Channel Breast MR Coil Kit 3T, GE Exite HDx 3T 7CH BBC, Philips 7ch SENSE Breast Coil 3T Siemens 3T Biopsy Breast Coil (7CH) 7 CHANNEL BREAST COIL 3T TRIO BIOPSY BREAST ARRAY Sense Breast Coil 3T 7ch dS 1.5T 4CH Lateral Right dS 1.5T 4CH Lateral Left dS Headrest dS 1.5T 8CH Medial dS 1.5T Interface Box dS Patient Support dS 1.5T Medial Plug dS 1.5T 1CH Lateral Right dS 1.5T 1CH Lateral Left SENSE SPINE COIL, 1.5T 15-CH Toshiba 1.5T 2Ch Breast Coil 1.5T Breast Coil Assembly Intera Achieva Panorama 1T 8ch Wrist Coil Smart Fit Shoulder 1.5T 0.6T Marconi Wrist and Hand Array Philips ST SENSE Wrist Coil ST SENSE Wrist Coil Ingenia Elition R5.7.1 SP4 MR Systems Philips Sense Head / Neck 8 Philips Sense Head / Neck 16 SENSE Head 16 SENSE Spine 16 Philips Sense Spine 8 Philips Sense Torso 16 Philips Sense Torso 8 Philips Sense Spine 16 INgenia 1.5T CX and Ingenia 3T CX R5.3 GE 1.5T 8C HEAD / BRAIN COIL VALUE SENSE Head Coil 1.5T/8CH 1.5T HD 8HR Brain Array for HDe (Receive Only) HD 8Ch HiRes Brain Array (Receive Only) Philips 1.5T SENSE Intera 8 Ch Head Coil GE 1.5T HDMR2-VALUE 8C HEAD / BRAIN, MA Head Coil, GE 1.5T LXI 8C HEAD (OEM) 8Ch High Resolution Brain Array (Receive Only) 8 Channel High Resolution Brain Coil MR 5300 and MR 7700 R11 MR Systems Philips SENSE NV Coil 3T 16Ch SENSE NV Coil 3T/16ch GE 0.7T LARGE OPENSPEED GENERAL PURPOSE COIL, GE 0.7T SMALL OPENSPEED GENERAL PURPOSE COIL, GE 0.7T MEDIUM OPENSPEED GENERAL PURPOSE COIL, Ingenia Elition X R5.4 Ingenia Elition S Quad Lower Extremity Coil (3T) GE, 1.5T HD, 8-Channel, Quad Extremity Coil Toshiba 1.5T 7Ch BBC 3T HD T/R Quad Extremity Coil (flat base) HD T/R QUAD EXTREMITY COIL 3T QUAD EXTREMITY COIL T/R GE, 3T HD, 8-Channel, Quad Lower Extremity Coil Philips INTERA 1.5T HNC 4Ch PA Quad Abdominal Flex Coil Toshiba 585 Series Phased Array coils. INgenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 Philips SENSE SPINE COIL 3T 15-ch, Philips SENSE SPINE COIL, 1.5T 15-CH SENSE Spine coil 1.5T 15-ch SENSE Spine Coil 3T 15-ch Achieva Family T/R HEAD COIL 3T 4598-001-5223x SENSE FLEX L COIL 3T ODU 4522-133-1722x SENSE FLEX M COIL 3T ODU 4522-133-1721x SENSE FLEX S COIL 3T ODU 4522-133-1720x MR 7700 Upgrade to MR 7700 SmartPath to Ingenia Elition X BlueSeal SE SmartPath to MR 7700 Ingenia Ambition X Ingenia Elition X Evolution Upgrade 1.5T Upgrades dStream to R12 SmartPath to dStream for 1.5T Evolution Upgrade 3T BlueSeal XE Ingenia Elition S MR 5300 Ingenia Ambition S SmartPath to dStream for 3T Panorama 1T Panorama HFO Gyroscan Intera (7.5) Gyroscan Intera 3T INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly GEMS and Clamp Stand INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly PHC and Clamp Stand INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, HITACHI INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly Skyra, SHC Needle Sleeve 16G Sentinelle, Biopsy Grid 459801508642 Breast Grid (User-Sterilized) 989603209144 Lateral Grid dS Breast 16CH I/T Breast Grid (User-Sterilized) 989603203484 MRI Needle Block 18G Pillar Immobilization Plate Pillar Immobilization Plate LBS M-L Lateral Grid, Lower dS Breast 16CH I/T Lateral Grid, Upper dS Breast 16CH I/T Needle Sleeve 18G 989603203464 MRI Needle Block 12G 989603203584 Mammotome Immobilization Plate 989603209104 Pillar Immobilization Plate Fiducial Marker Grid Block Assembly Needle Sleeve 12G Fiducial Holder Needle Sleeve 14G 989603203594 OBC Grid Immobilization Plate 989603214204 Biospy Grid, Sterilized Pillar Immobilization Plate BBC Needle Block, 16G 989603209064 Grid Immobilization Plate LBS MRI Needle Block 8G Needle Block, 12G Pillar Immobilization Plate LBS C-C Fiducial Marker Sleeve Assembly Needle Block Holder MRI Needle Sleeve 12G Pillar Immobilization Plate BBC Grid Immobilization Plate LBS C-C Grid Plate, Enhanced Access Lateral Grid Immobilization Plate LBS M-L Medial Grid dS Breast 16CH 1/T 459801507722 Biospy Grid, Sterilized 989603203474MRI Needle Block 14G Grid Plate, Enhanced Access Medial 989603203574 Pillar Immobilization Plate OBC INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly SMS and Clamp Stand 989603203524 Grid Immobilization Plate Needle Hub Assembly 989603204304 MRI Needle Block 16G INVIVO (FLORIDA, USA): DynaTRIM Complete, HITACHI DynaTRIM Grid Immobilization Plate OBC INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, GEMS Biopsy Grid Needle Block, 14G INVIVO (FLORIDA, USA): DynaTRIM Complete, Skyra Baseplate assembly SHC and Clamp Stand Grid Immobilization Plate BBC INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, SMS Needle Block, 18G Lateral Grid dS Breast 16CH 1/T INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, PHC INVIVO (FLORIDA, USA): DynaTRIM Clamp stand assembly INVIVO (FLORIDA, USA): DynaTRIM Complete, GEMS DynaTRIM GE 1T Signa 4CH OBC GE Excite HDe 1.5T 4CH (HDMR2-VALUE 4C OBC) GE 1.5T SIGNA 4C PA OBC GE Excite HD 1.5T 4 Channel Breast Coil Breast Array Coil BREAST ARRAY COIL (Receive Only) dS Flex Coil L (3T) dS Anterior Coil (3T) dS Anterior Coil (1.5T) dS Flex Coil S (3T), dS Flex Coil M (1.5T), dS Flex Coil M (3T), dS Flex Coil L (1.5T) dS Head-Neck Coil (3T), dS Head Coil (1.5T), dS Head Coil (3T), dS Flex Coil S (1.5T) FRU, COIL ASSY, PHC 1.5T 16CH 1.5T AND 3T GENERAL PURPOSE FLEX COILS dS FLEX-L 1.5T dS FLEX-M 3T dS FLEX-M 1.5T dS FLEX-L 3T dS Anterior 1.5T dS FLEX-S dS Anterior Coil (3T), dS Base Coil (1.5T), dS Base Coil (3T), dS Head-Neck Coil (1.5T) dS Anterior 3T dS FLEX-S 1.5T dS Flex Coil S (1.5T) GE 1.5T Excite HDx 1.5T KFC DS (Quadrature Lower Extremity Coil) GE, 1.5T HD, 8-Channel, Quad Extremity Coil GE, 3T HD, 8-Channel, Quad Lower Extremity Coil QUADRATURE KNEE / FOOT COIL HD T/R QUAD EXTREMITY COIL 1.5T HD T/R QUAD EXTREMITY COIL (flat base) Quardrature Knee/Foot Coil 1.5T QUAD EXTREMITY COIL T/R GE 1.5T Quadrature Lower Extremity Coil (KFC DS) 3T HD T/R Quad Extremity Coil (flat base) Siemens 3T 8-CHANNEL HRH COIL (High Res Head Array), 8 Channel Head Array GE 0.5T SP Tx/Rx INTERVENTIONAL SPINE ARRAY Philips SENSE Head Coil, 8Ch 3T, SENSE Head Coil, 6Ch 3T ST SENSE Breast Dx Coil Sentinelle, Biopsy Grid Kit, Enhanced Access, Bilateral Upgrade Breast 7 Biopsy Pack, 1.5T Philips 4-ch SENSE NeuroVascular Coil 3T 3T SENSE MEDIUM GP FLEX 8 dS FootAnkle Coil 8ch 1.5T GE Signa Excite III Brain Coil Philips dS Head 32ch 3T GE Signa Excite II Brain Coil Philips SENSE Intera Achieva 3T Brain Coil GE Signa Excite I Brain Coil dS Head 32ch 3T SENSE Head Coil 3T 32 1.5T/3T 8 ch medium general purpose Flex Coil SENSE MASK M 8Ch 1.5T Siemens 1.5T ESPREE 8Ch FAC Siemens 1.5T Symphony 8Ch FAC GE Excite 3T HDx 8Ch FAC Siemens 3T Tim/Trio 8Ch FAC (Foot/Ankle Coil) GE Excite HDx 1.5T HDx 8Ch 1.5T FAC Siemens 8 Channel Foot Ankle MR Coil Kit Verio 3T GE HD 1.5T 8C Foot and Ankle SMS 1.5T Espree 8Ch FAC (Foot/Ankle Coil) Siemens Avanto 1.5T 8Ch FAC (Foot/Ankle Coil) Siemens 3T TIM/TRIO 8Ch FAC Philips dS 1.5T 8-ch Foot Ankle Coil Philips SENSE Foot-Ankle Coil 1.5T 8ch Siemens 1.5T AVANTO 8Ch FAC Philips SENSE Foot-Ankle Coil 3T 8ch GE Excite 1.5T 8Ch Foot and Ankle Coil (FAC) GE HD 3T 8C Foot and Ankle Philips dS 3T 8-ch Foot Ankle Coil 8 Channel Foot Ankle MR Coil Kit 3T 8 Channel Foot Ankle MR Coil Kit 1.5T dS FOOTANKLE 8CH 1.5T HD 8Ch Foot Ankle Coil HD 8CH Foot Ankle Coil (Receive Only) dS FootAnkle 8Ch 3T dS Foot-Ankle Coil 8ch 3T SIEMENS 8 CHANNEL FOOT AND ANKLE ARRAY SENSE Foot-Ankle Coil 8CH FOOT ANKLE MR COIL 3T 8 CHANNEL FOOT ANKLE COIL 1.5T Achieva Ingenia Ingneia CX Ingenia Ambition Intera Ingenia Elition Siemens 1.5T HIGH-RESOLUTION SHOULDER ARRAY Philips dS 3T MIRA 8C SENSE SHOULDER- Philips GE 3T Signa Excite 8CH Shoulder Philips SENSE Shoulder Coil 3T Siemens 1.5T VISION SHOULDER [DIR] Philips dS Shoulder 8ch 1.5T Siemens 3T 8CH SHOULDER Siemens 3T Precision Shoulder Array (8Ch) Philips SENSE Shoulder Coil 1.5T Siemens 1.5T Precision Shoulder Array GE 1.5T Signa Excite 8CH Shoulder 1.5T 8CH Obelix digital shoulder coil SENSE Shoulder Coil 3T 1.5T Precision Shoulder Array 3T Precision Shoulder Array dS Shoulder 8ch 1.5T dS Shoulder 8ch 3T SENSE Shoulder Coil 1.5T Philips dS Breast 7ch 1.5T Toshiba 1.5T 7CH BBC GE Excite 1.5T 7CH BBC Toshiba 1.5T 7Ch BBC Philips dS Breast 7ch 3T Grid Immobilization Plate BBC, Pillar Immobilization Plate BBC, Pillar Immobilization Plate, GE LBS 3T 16CH MammoTrak Interventional Breast Coil 1.5T Philip Interventional Coil 3T, PHC, Achieva TX Siemens Luminescence 1.5T Breast Coil 7 Ch Coil/ASM/Breast Coil for Echelon LBS 3T SMS 7 ch GE LBS 1.5T16CH GE Excite HDx 1.5T HDx 7CH BBC Siemens 1.5T Symphony 7Ch BBC (Breast Biopsy Coil) Siemens Luminescence 1.5T Breast Coil 16 Ch HITACHI 1.5T 7C BREAST GE HDx 3T 7Ch Biopsy Breast GE LBS 3T 7CH Biopsy Breast Coil Grid Immobilization Plate LBS, Pillar Immobilization Plate LBS, Needle Block Holder, GE Excite HDx 1.5T 7ch BBC Siemens AVANTO 1.5T BBC Siemens Luminescence 3T Breast Coil 16 Ch Philips 7ch SENSE Breast Coil 1.5T GE Excite 1.5T 7Ch Biopsy Breast Array dS Breast 16ch 1.5T dS Breast 7ch 3T dS Breast 7ch 1.5T SENSE Breast Coil 7ch BREAST SPEEDER AVANTO BIOPSY BREAST ARRAY Fiducial Holder, Needle Hub Assembly, Siemens SYMPHONY 1.5T BBC Mammotrak Interventional Coil 1.5T Achieva TX Interventional Coil 3T PHILIPS 1.5T INTERA ACHIEVA (CDAS) BBC 4Ch Right Lateral Coil Sen 1.5T PATIENT SUPPORT BREAST SEN Medial Array Coil VS 16Ch Sentinelle Breast MRI Tabletop with 16 Channel Coil Array For Siemens 1.5/3T MRI Systems Single Loop Coil Left VS Interface Box VS 16Ch 1Ch Left Coil Element Sen 3T Lateral Array Coil Left VS 16Ch 1Ch Right Coil Element Sen 1.5T 16Ch Interface Box Breast Coil Sen 3T 4Ch Left Lateral Coil Sen 1.5T Single Loop Coil Right VS Medial Plug Sen 3T 16Ch Interface Box Breast Coil Sen 1.5T Medial Plug Sen 1.5T 1Ch Right Coil Element Sen 3T 1Ch Left Coil Element Sen 1.5T Lateral Array Coil Right VS 16Ch 8Ch Medial Coil Sen 3T Medial Plug VS 4Ch Left Lateral Coil Sen 3T 4Ch Right Lateral Coil Sen 3T 8Ch Medial Coil Sen 1.5T SENTINELLE BREAST MRI 16CH Tabletop for Siemens 1.5T Vanguard for Siemens Breast MRI Auxillary Table SENTINELLE BREAST MRI 16CH Tabletop for Siemens 3T SENTINELLE BREAST MRI 8CH Tabletop for Siemens 1.5T 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil Gyroscan Intera Intera Sensation Family QSC-085 Shoulder Array Coil dS FootAnkle 16 Ch 1.5T Coil dS FootAnkle 16Ch 1.5T dS Shoulder 16Ch 3T 3T 16Ch GE Shoulder Coil 1.5T 16Ch GE Shoulder Coil dS 1.5T 16CH SHOULDER, COIL dS 3T 16CH SHOULDER, COIL 16Ch Shoulder Coil dS Shoulder 16Ch 1.5T BREAST ARRAY COIL, Philips 4-ch SENSE Breast Coil 3T 4-ch SENSE Breast Coil 3T GE Excite HD 1.5T 4 Channel Wrist Coil (HRW-GE SIGNA) MA Wrist Coil GE 1.5T HDMR2-VALUE 4C WRIST COIL HD 4CH Wrist Array (Receive Only) HIGH RESOLUTION WRIST COIL(Receive Only) GE 1.5T 4C PA WRIST (OEM) Intera I/T MR system

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2018-08-14
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-08-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-04-11
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-04-11
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2021-11-22
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-11-22
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-04-03
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-18
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-12-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-26
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-15
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2016-03-29
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-26
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-26
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2015-05-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-02-19
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2019-02-19
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2022-04-06
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-12-02
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-11-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2006-02-21
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-01-03
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-05-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-05-01
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-03-04
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-03-04
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2021-11-09
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2021-11-09
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2021-11-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2019-06-12
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2019-06-12
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2006-05-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-08-20
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2025-08-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-12-02
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2022-04-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2012-02-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2011-03-23
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-01-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-26
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-09-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-04-14
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-04-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-26
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2026-03-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-03-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-05-17
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-05-17
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-09-02
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2008-11-12
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-09-02
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-04-03
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-08-10
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-08-10
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-04-26
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2017-01-10
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2017-01-10
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-18
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-01-03
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-01-03
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-18
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2018-03-07
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2018-03-07
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-18
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2017-01-09
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2017-01-09
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-06-16
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2025-06-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-06-09
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 1992-11-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-02-25
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-18
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-02-19
PXP Breast Biopsy / Localization Tray General, Plastic Surgery Class 1 878.4800 2022-09-09
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-12-02
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2012-05-10
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2020-04-14
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2020-04-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2021-10-28
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-09-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-15
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-09-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-09-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-18
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-20
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-15

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Heiling Business: PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV Email: maria.heiling@philips.com Phone: (858) 2487651

Related Public Records

Same Entity

Philips Medical Systems International BV
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3038281851 Philips Polska Sp. z o.o. Lodz Lodzkie, PL
3003584029 Braemar Manufacturing, LLC San Diego, CA, US
3042175841 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Best Noord-Brabant, NL
3008514395 Telcare, LLC Linwood, PA, US
3004961434 RESPIRATORY TECHNOLOGIES, INC. Plymouth, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243985 Icu Medical, Inc. Rio™ Drug Reconstitution Transfer Device 2025-01-22
K222718 Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Vial Adapter 2023-03-10
K033504 General Electric Co. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 2003-11-25
K013636 GE Medical Systems SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 2002-01-24
K250443 Siemens Healthcare GmbH MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile 2025-06-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2017 Baxter Corporation Englewood 2
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014 Philips Medical Systems (Cleveland) Inc 2
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024 Philips North America Llc 2
Achieva 1.5T
Z-0390-2024 Philips North America Llc 2
Achieva 1.5T Conversion

Similar Registrations

Registration Number Establishment Name Location
3043226252 ZAPALIGN LLC Fort Lauderdale, FL, US
2523676 B. BRAUN US DEVICE MANUFACTURING LLC ALLENTOWN, PA, US
3016418550 Takeda Pharmaceuticals U.S.A., Inc. Cambridge, MA, US
3012798826 BD SWITZERLAND SARL Eysins Vaud, CH
2032098 Isomedix Operations, Inc ONTARIO, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042177665. Last updated year: 2026. Please use registration number 3042177665 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.