Philips Global Business Services LLP

FDA Device Registration & Listing · Pune Maharashtra, IN · Registration 3016851825

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
3016851825
FEI Number
3016851825
Entity Name
Philips Global Business Services LLP
City/State/Country
Pune Maharashtra, IN
Establishment Address
B-78/B-79, MIDC, Chakan Industrial area Phase 2, Pune Maharashtra 410501, IN
Establishment Type(s)
Manufacture Medical Device
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

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 GE 3T 32 Channel Cardiac Coil (Anterior Only) GE 1.5T 32 Channel Cardiac Coil- Anterior Only SMS 1.5T 32 Channel Cardiac Coil GE 3T 32 Channel Cardiac Coil PHILIPS 3T INTERA ACHIEVA 32C CARDIOVASCULAR Siemens 1.5T AVANTO 32C CARDIOVASCULAR GE 3T 32 Channel Cardiac Coil (Posterior) Siemens 1.5T 32 CHANNEL CARDIAC Siemens 3T TRIO A TIM 32C CARDIOVASCULAR GE 3T 32 Channel Cardiac Coil- Anterior Only Siemens 3T 32 CH BAC Philips SENSE Torso/Cardiac Coil 1.5T GE 1.5T 32 Channel Cardiac Coil (Anterior) GE 3T 32 Channel Cardiac Coil- Anterior and Posterior GE Cardiac Coil, 1.5T, 16ch GE 3T 32 Channel Cardiac Coil (Anterior) GE 1.5T 32 Channel Cardiac Coil SMS 3T 32 Channel Cardiac Coil GE 1.5T 32 Channel Cardiac Coil (Posterior) 3T 32Ch Cardiac Coil - Anterior 1.5T 32Ch Cardiac Coil- Anterior 1.5T 32CH Cardiac Coil- Anterior SENSE Torso/Cardiac Anterior Coil 3T 32Ch CardiaC Coil- Anterior 16 Ch Body Array Anterior 3T SENSE Torso/Cardiac Posterior Coil 16 Ch Body Array Anterior 1.5T 3T 32Ch Cardiac Coil- Posterior 1.5T 16CH Cardiac Coil- Anterior 1.5T 16CH Cardiac Coil- Posterior 32 Ch Head dS Head 32ch 3T Siemens Verio 3T Brain Coil GE 16 Ch Knee Coil 3T Siemens 1.5T 16 Channel Knee Coil Philips SENSE Knee Coil 16Ch 3T Siemens Trio 3T Brain Coil Philips dS Knee 16ch 1.5T GE 16 Ch Knee Coil 1.5T Philips SENSE Knee Coil 16Ch 1.5T Siemens 3T 16 Channel Knee Coil Philips dS T/R Knee 16ch 3T dS Knee 16 ch 1.5T dS SMALL EXTREMITY 16CH 1.5T Sense Knee 8ch 3T dS Knee Coil 16ch 1.5T SENSE Knee Coil 16CH TX dS T/R Knee 16ch 3T SENSE Knee Coil 16CH 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 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 Philips 3T SENSE GP Flex 8 1.5T SENSE GP Flex 8 SENSE XL Torso Coil Shoulder Array MR Coil kit VERIO, Siemens 3T VERIO, QSC, Siemens QSC SET, TRIO/TIM 3T 4CH SHOULDER ARRAY COIL SET 4 CH Shoulder Large - 4 CH Shoulder Small SHOULDER ARRAY SMALL SHOULDER ARRAY LARGE OBC-250-PAN BREAST ARRAY COIL 0.6T Panorama 4Ch Breast Array ST SENSE Breast Coil BREAST ARRAY COIL, Philips 4-ch SENSE Breast Coil 3T 4-ch SENSE Breast Coil 3T Sentinelle, Biopsy Grid Kit, Enhanced Access, Bilateral Upgrade Breast 7 Biopsy Pack, 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) Vanguard MRI Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems Medial Single Loop Coil Left VG STR Medial Coil Element Sen 1.5T 3Ch Left Coil Element Sen 1.5T Interface Box Breast Coil Sen 3T Medial Coil Element Sen 3T Interface Box Breast Coil Sen 1.5T Lateral Single Loop Coil Left VG STR Lateral Array Coil Left VG STR Medial Array Coil VS 8Ch Lateral Array Coil Left VS 8Ch Medial Array Coil VS Cable Tray HYP VG STR Lateral Array Coil Right VG STR 3Ch Right Coil Element Sen 1.5T Interface Box VS 8Ch Medial Array Coil VG STR Medial Plug VG STR Vanguard Breast MRI Table 3Ch Right Coil Element Sen 3T Vanguard Atlas/Titan Medial Single Loop Coil Right VG STR Lateral Array Coil Right VS 8Ch 3Ch Left Coil Element Sen 3T Lateral Single Loop Coil Right VG STR Breast MRI 8ch Table for GE 1.5T 1.5T Breast Speeder 8ch Breast MRI 8ch Tabletop for Siemens 1.5T dS Knee Coil 8ch 1.5T 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 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 16 Breast Coil 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil dS FootAnkle Coil 8ch 1.5T Siemens 3T 8-CHANNEL HRH COIL (High Res Head Array) Accessories, SENSE Head Coil, 6Ch 3T Philips SENSE Head Coil, 8Ch 3T SENSE Head Coil 3T/8CH SENSE Head Coil, 6Ch 3T 8 Channel Head Array 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 SENSE NV Coil 3T 8Ch SENSE NV Coil 3T/8ch 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 Siemens Symphony Shoulder Coil GE Excite HD 1.5T 4 Channel Shoulder Coil Siemens AVANTO SHOULDER ARRAY COIL SET GE 1.5T SIGNA 4C PA SHOULDER Expert Shoulder Array Baseplate Hitachi 1.5T Echelong PA Shoulder Siemens 1.5T AVANTO QUAD SHOULDER COIL S Siemens ESPREE SHOULDER ARRAY COIL SET Siemens 1.5T ESPREE QUAD SHOULDER COIL S Siemens AVANTO SHOULDER COIL BASEPLATE UPGRADE Large Shoulder Array Coil (Receive Only) Shoulder Array Coil Small Shoulder Array Coil Large Shoulder Array Coil Set dS FootAnkle 16 Ch 1.5T Coil dS FootAnkle 16Ch 1.5T 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 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 Avanto/Espree 1.5T 8Ch High Resolution Knee Array GE EXCITE 1.5T SIGNA HD 8C Tx/Rx KNEE (OEM) GE EXCITE 1.5T 8 CHANNEL T/R , High Res Knee Array Coil (HRK) 8 Channel Knee Array MR Coil Kit Avanto, Siemens HRK, AVANTO 1.5T 8CH PA 1.5T HD T/R KNEE ARRAY 1.5T HD T/R Knee Coil (flat base) HIGH RESOLUTION T/R KNEE COIL 8CH HIGH RESOLUTION KNEE ARRAY 3T HD T/R KNEE ARRAY Mammotrak Diagnostic Coil 3T Philips MammoTrak Interventional Breast Coil, 3T, 7CH Philips dS Breast 16ch 3T Siemens 16 CH Breast 3T (LBS) MammoTrak Interventional Breast Coil 3T Philips dS Breast 16ch 1.5T MammoTrak Diagnostic Breast Coil 1.5T Mammotrak Diagnostic Coil 1.5T Mammotrak Interventional Coil 3T dS Breast 16ch 3T Philips MammoTrak Interventional Breast Coil, 3T, 16CH dS Breast 16ch 1.5T dS 3T Medial Plug dS 3T 8CH Medial dS 3T 1CH Lateral Left dS 3T 4CH Lateral Left dS 3T 4CH Lateral Right dS 3T 1CH Lateral Right dS 3T Interface Box Toshiba 1.5T 2Ch Breast Coil 1.5T Breast Coil Assembly 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 dS Wrist Coil 8ch 1.5T ds Wrist Coil 8ch 1.5T, Dlisting D551129 4-ch SENSE Wrist Coil 1.5T INTERA 1.5T High Res Wrist Coil PA, Philips 4-ch SENSE Wrist Coil 1.5T 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 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 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 dS Small Extremity 16Ch 1.5T Coil dS Small Extremity 16ch 3T dS Small Extremity 16Ch 3T 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) 0.6T Marconi Wrist and Hand Array Philips ST SENSE Wrist Coil ST SENSE Wrist Coil 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 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 dS Breast 16CH 1.5T Philips 1.5T Intera 16ch SENSE NV Array Grid dS Breast 16CH I/T dS Breast 16 CH I/T 1.5T; dS Breast 16 CH I/T 3T Philips SENSE NV Coil, 1.5T 8Ch Sense NV 16 channels Philips dS Breast 16ch 1.5T Philips dS Breast 16ch 3T dS Breast 16CH 3T I/T dS Breast Adaptive 16CH 3T dS Breast Adaptive 16CH 1.5T 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 1.5T HDMR2-VALUE 8C NVA, MA Neurovascular Coil, GE 1.5T SIGNA EXCITE 8C NVA COIL (OEM), GE Excite HD 1.5T 8-CHANNEL NVA COIL GE Excite HDx 1.5T 8 Channel Neurovascular Array 8Ch Neuro Vasculat Array (Receive Only) HD 8Ch NV ARRAY 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 Siemens HRK, TRIO/TIM 3T 8CH Siemens 3T 8Ch High Resolution Knee Array GE 3T HD Tx/Rx 8C KNEE GE, 1.5T 8CH T/R Knee COIL GE Excite 3T HDx Tx Rx KNEE COIL GE, 3T 8CH T/R Knee COIL 8 CHANNEL KNEE COIL Siemens Trio 3T 8 Channel T/R HRK (High Res Knee) 3T HD T/R Knee Coil (flat base) 3T HD T/R KNEE ARRAY 8 Ch High Resolution Knee Array

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-18
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
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
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
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
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2010-04-08
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 2009-05-18
PXP Breast Biopsy / Localization Tray General, Plastic Surgery Class 1 878.4800 2022-09-09
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2015-05-01
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 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-11-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-09-02
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 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 2022-09-02
LNH System, Nuclear Magnetic Resonance Imaging 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 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2006-05-09
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 2022-09-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-04-26
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
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 1992-11-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-12-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-02-25
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2016-09-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2013-01-03
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2009-05-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-18
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2015-05-01
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2009-05-19

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Heiling Business: Philips 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
K121249 Paramed S.R.L. MULTIARRAY KIT 2012-06-12
K000935 Mri Devices Corp. KFA-63 KNEE AND FOOT ARRAY 2000-04-07
K102889 Hitachi Medical Systems America, Inc. HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON 2010-12-20
K110373 Esaote, S.p.A. TEMPOROMANIBULAR COIL 15 2011-04-06
K030317 Midwest Rf, LLC MODEL 1300GE-64: PEDIATRIC POSITIONER 2003-03-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2020 Quality Electrodynamics LLC 2
TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460
Z-0032-2020 Quality Electrodynamics LLC 2
TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
Z-0033-2020 Quality Electrodynamics LLC 2
TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464
Z-0034-2020 Quality Electrodynamics LLC 2
TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524
Z-0035-2020 Quality Electrodynamics LLC 2
TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

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3006369484 NEOCOIL, LLC Pewaukee, WI, US
3010703925 MAKAR CONSULTING PTY LTD Belrose New South Wales, AU
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016851825. Last updated year: 2026. Please use registration number 3016851825 when referencing this establishment in official correspondence.
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