Philips North America LLC

FDA Device Registration & Listing · ANDOVER, MA, US · Registration 1218950

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
1218950
FEI Number
1218950
Entity Name
Philips North America LLC
City/State/Country
ANDOVER, MA, US
Establishment Address
3000 Minuteman Rd, ANDOVER, MA 01810, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
K113125
PMA Number
N/A

All Registered Proprietary Names

13955C Neonatal/Pediatric Snap Electrode, Square 13953E Radiolucent Preattached Leadwire Electrode, Square 13953D Metallic Preattached Leadwire Electrode, Square 13952D Metallic Preattached Leadwire Electrode, Medium 13951C Neonatal/Pediatric Solid Gel Electrode 13952A Preattached Leadwire Electrode medium 13953B Preattached leadwire electrode square 13952B Preattached Leadwire electrode medium 13953A Preattached Leadwire electrode square DigiTrak XT Holter Recorder w/Leadwires DL950 Holter System 989803163201 Mobile CL Disposable Adult Cuff 989803163191 Mobile CL Reusable Adult Cuff 989803163181 Mobile CL Disposable Small Adult Cuff 989803163221 Mobile CL Disposable Large Adult Cuff IntelliVue Multi-Measurement Module X2, SW Rev. H1 IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H1 IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D Diverse Specialized Accessories and IntelliVue CL 865220 charging station 989803163211 Mobile CL Reusable Large Adult Cuff IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A 989803163251 Mobile CL NBP Cradle Kit 989803168881 Mobile CL Transmitter Cradles 989803203561 Esophageal/Rectal Temperature Probe 12 Fr, Reusable, Autoclavable 21075A Esophageal/Rectal 12 Fr Temperature Probe 21078A Skin Surface Temperature Probe 989803203571 Esophageal/Rectal Temperature Probe 10 Fr, Reusable, Autoclavable 989803203581 Skin Temperature Probe, Reusable, Autoclavable 21076A Esophageal/Rectal 10 Fr Temperature Probe 989803192931, SureSigns VS Temporal Temperature HH 989803180831, Genius 2 tympanic temperature probe 863286, SureSigns VS4 Government Bundle 13943B Solid Gel Tab Electrode, Resting ECG 989803148821 Radiolucent Foam Electrode M1872S Neonatal Soft Single-Patient Cuff Size#4 989803167551 Neonatal Soft Single-Patient NIBP Cuffs M1868S Neonatal Soft Single-Patient Cuff Size#2 M1866S Neonatal Soft Single-Patient Cuff Size#1 M1872B Neonatal Single-Patient Cuff Size #4 M1873S Infant Soft Single-Patient Cuff Size #5 M1866B Neonatal Single-Patient Cuff Size #1 989803167541 Neonatal Single-Patient NIBP Cuffs M1868B Neonatal Single-Patient Cuff Size #2 M1870S Neonatal Soft Single-Patient Cuff Size#3 M1873B Infant Single-Patient Cuff Size #5 M1870B Neonatal Single-Patient Cuff Size #3 INTELLIVUE MX40 PATIENT MONITOR 989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele 989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele 989803199081 MX40 Adapter SpO2-only 989803171831 ECG 5 lead Grabber, AAMI, Tele 989803199101 MX40 Adapter 3L+SpO2 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele 989803171971 CBL ECG 6 Lead Grabber, IEC+SpO2, Tele 989803199071 ECG 6 lead Grabber, IEC + SpO2, Tele 989803171871 CBL ECG 6lead Grabber, AAMI + SpO2, Tele 989803171931 ECG 5 lead Grabber, IEC, Tele 989803171961 ECG 6 lead Grabber, IEC, Tele 989803171861 ECG 6 lead Grabber, AAMI, Tele 989803171821 ECG 5 lead Snaps, AAMI, Tele 989803199091 MX40 Adapter 5L+SpO2 989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele 989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele MX40 Release B7 989803156201 Adult Disposable Metallic 3 Leadwire Electrode Set, AAMI 989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI 989803156231 Adult Disposable Radiolucent 3 Leadwire Electrode Set, IEC 989803156221 Adult Disposable Radiolucent 3 Leadwire Electrode Set, AAMI 989803156261 Adult Disposable Radiolucent 5 Leadwire Electrode Set, AAMI 989803156271 Adult Disp Radiolucent 5 Leadwire Electrode Set, IEC Telemetry Monitoring System Snap Style Foam Electrode 989803101301 HI-Tack Foam Wet Gel ECG Electrode 40420A HI-Tack Foam Wet Gel ECG Electrode Blood pressure monitor IntelliSpace ECG IntelliSpace ECG SW B800-11 BilEclipse, 50 Pack M4612A Solid Gel Foam Electrode 989803192551 Clear Tape Wet Gel ECG Electrode M4613A Solid Gel Foam Electrode Philips ST/AR ST 989803205391 Philips Nasal Alar SpO2 Sensor 989803205381 Philips Nasal Alar SpO2 Sensor 989803205401 Philips Nasal Alar SpO2 Sensor B800-500 BiliCal; 50 Pack 1037632 Bilichek (Advanced) 989803183081 Mini NeoLead, AAMI metal lead 989803183121 NeoLead, AAMI radio lead 989803183101 989803183101 989803183141 Micro NeoLead, AAMI radio lead CareEvent Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A) Avalon Fetal & Maternal Patch Avalon Patient Module (M2738A) Avalon CL Fetal & Maternal Pod (866488) M1911A Fetal Monitoring Recording Paper Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA) Avalon Basestation (866074) Remote Event Marker (989803143411) 989803184851- Avalon Belt Clip M1910A Fetal Monitoring Recording Paper M2734B MECG Adapter Cable (M1363A) M1913J Fetal Monitoring Recording Paper M1913A Fetal Monitoring Recording Paper M2202A Radiolucent Foam Electrode M1532A ECG Cable M1672A ECG Cable EEG Leadset - 989803180531 M1976A ECG Cable M1663A ECG Trunk Cable EEG Leadset - 989803180561 M1680A ECG Cable M1979A ECG Cable M1602A ECG Cable M1626A ECG Cable M1669A ECG Trunk Cable M1665A ECG Trunk Cable M1681A ECG Cable M1673A ECG Cable M1968A ECG Cable M1644A ECG Cable M1675A ECG Cable M1624A ECG Cable M1949A ECG Trunk Cable M1671A ECG Cable M1674A ECG Cable M1978A ECG Cable M1645A ECG Cable M1973A ECG Cable EEG Leadset - 989803180521 M1667A ECG Trunk Cable M1974A ECG Cable M1971A ECG Cable M1678A ECG Cable M2268A EEG Trunk Cable M1934A EEG Leadset CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171 M1668A ECG Trunk Cable EEG Leadset - 989803180541 CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161 M1533A ECG Cable CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181 989803157501, DigiTrak XT Patient Cable, Long 989803157481, DigiTrak XT Patient Cable, short 989803157491, DigiTrak XT Patient Cable, Medium BTP-1000L-2-Lead Wire Adapter Flex Adapter BTP-1000A-Hybrid Patch Lead Wire Adapter OMNI-TRAK 3000 SERIES SureSigns VS Temporal Temperature HH - 989803192931 Philips IntelliVue Information Center iX, M3290B Software 989803183311 Multi Care Cuff, Infant 989803183361Multi Care Cuff, Large Adult 989803183351 Multi Care Cuff, Adult XL 989803183321 Multi Care Cuff, Pediatric 989803183371 Multi Care Cuff, Thigh 989803183331 Multi Care Cuff, Small Adult 989803183341 Multi Care Cuff, Adult M1572A Comfort Care Cuff, Pediatric M1573A Comfort Care Cuff, Small Adult M1575A Comfort Care Cuff, Large Adult M1574A Comfort Care Cuff, Adult M1571A Comfort Care Cuff, Infant M1576A Comfort Care Cuff, Thigh M1574XL Comfort Care Cuff, Adult XL 40477A Chemical/Thermal Paper M3708A Chemical/Thermal Paper M4816A Thermal Paper M2485A Chemical/Thermal Paper 989803190381 Efficia 50mm Chemical Thermal Paper, No Gridlines M4817A Thermal Paper 989803185271 Thermal Roll Paper, 110 mm Wide 989803138171 Defibrillator Chemical/Thermal Paper M3707A Chemical/Thermal Paper M2481A Chemical/Thermal Paper M1710A Chemical/Thermal Paper M2483A Chemical/Thermal Paper 40457C Chemical/Thermal Paper 989803138181 Defibrillator Chemical/Thermal Paper 989803151771, 15/16/18-Lead Upgrade Kit (AAMI), Long 989803151641, 12-Lead Complete Lead Set (IEC), Standard Length 989803164281, USB Patient Data Cable, Class B 989803151781, 15/16/18-Lead Upgrade Kit (IEC), Long 989803151661, 12-Lead Complete Lead Set (IEC), Long 989803151691, 12-Lead Chest Lead Set (AAMI/IEC), Long 989803151711, 12-Lead Limb Lead Set (AAMI/IEC), Standard Length 989803151671, 12-Lead Chest Lead Set (AAMI/IEC), Standard Length 989803151751, 15/16/18-Lead Upgrade Kit (AAMI), Standard Length 989803151651, 12-Lead Complete Lead Set (AAMI), Long 989803151761, 15/16/18-Lead Upgrade Kit (IEC), Standard Length 989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length 989803151731, 12-Lead Limb Lead Set (AAMI/IEC), Long CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC - 989803170181 CBL OR 3-Lead ECG Trunk Cable, AAMI/IEC - 989803170171 Intellivue MX40 Patient Monitor 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2012-03-22
MWJ Electrocardiograph, Ambulatory (Without Analysis) Cardiovascular Class 2 870.2800 2009-03-11
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2010-10-19
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2010-10-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2010-10-19
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2010-10-19
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2010-10-19
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2010-10-19
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2010-10-19
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2010-10-19
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2010-10-19
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2010-10-19
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2010-10-19
DQA Oximeter Cardiovascular Class 2 870.2700 2010-10-19
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2010-10-19
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-06-09
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2015-11-03
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2015-11-03
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2015-11-03
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2015-11-03
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2026-04-06
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2012-03-22
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2011-06-09
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2011-08-31
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2018-05-14
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2018-05-14
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2018-05-14
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2018-05-14
DQA Oximeter Cardiovascular Class 2 870.2700 2018-05-14
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2018-05-14
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2018-05-14
DRW Adaptor, Lead Switching, Electrocardiograph Cardiovascular Class 2 870.2350 2018-05-14
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2012-03-22
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2009-02-19
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-02-19
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Cardiovascular Class 2 870.4330 2009-02-19
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2012-07-10
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2016-01-28
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-02-19
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2010-08-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2010-08-10
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2010-08-10
DQA Oximeter Cardiovascular Class 2 870.2700 2018-10-04
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2008-04-16
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2013-10-24
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2019-10-14
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2014-12-01
HFM Monitor, Uterine Contraction, External (For Use In Clinic) Obstetrics/Gynecology Class 2 884.2720 2014-12-01
DSF Recorder, Paper Chart Cardiovascular Class 1 870.2810 2014-12-01
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2014-12-01
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2014-12-01
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2014-12-01
DQA Oximeter Cardiovascular Class 2 870.2700 2014-12-01
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2014-12-01
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-12-01
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2014-12-01
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2014-12-01
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2014-12-01
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2014-12-01
HGL Transducer, Ultrasonic, Obstetric Obstetrics/Gynecology Class 2 884.2960 2014-12-01
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic Cardiovascular Class 2 870.2780 2014-12-01
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2014-12-01
DRQ Amplifier And Signal Conditioner, Transducer Signal Cardiovascular Class 2 870.2060 2014-12-01
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2014-12-01
HFN Transducer, Pressure, Intrauterine Obstetrics/Gynecology Class 2 884.2700 2014-12-01
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2014-12-01
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2011-11-28
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2003-11-12
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2014-11-21
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2014-11-21
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-11-21
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2014-11-21
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2014-11-21
DQA Oximeter Cardiovascular Class 2 870.2700 2014-11-21
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2016-02-26
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2009-10-29
DSF Recorder, Paper Chart Cardiovascular Class 1 870.2810 1992-10-13
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2009-02-03
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2009-10-29
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2015-04-21
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2015-04-21
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2015-04-21
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2015-04-21
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2015-04-21
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2015-04-21
DQA Oximeter Cardiovascular Class 2 870.2700 2015-04-21
DRW Adaptor, Lead Switching, Electrocardiograph Cardiovascular Class 2 870.2350 2015-04-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K934333 3M Medical Products Group 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 1994-07-07
K771977 Instrumentation Laboratory CO CARDIAC OUTPUT COMPUTER MODEL 701 1978-01-03
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2010 Philips Healthcare Inc. 3
HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0011-2013 Philips Healthcare Inc. 3
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
Z-0015-2018 Philips Electronics North America Corporation 2
Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Z-0016-2018 Philips Electronics North America Corporation 2
Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Z-0017-2018 Philips Electronics North America Corporation 2
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Z-0018-2018 Philips Electronics North America Corporation 2
Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Z-0019-2018 Philips Electronics North America Corporation 2
Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Z-0020-2018 Philips Electronics North America Corporation 2
Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Z-0022-2015 Philips Medical Systems, Inc. 2
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0284-2021 Philips North America, LLC 3
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery.
Z-0285-2021 Philips North America, LLC 3
Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery.
Z-0489-2018 Philips North America, LLC 3
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Z-0498-2020 Philips North America, LLC 3
HeartStart XL+ Defibrillator/Monitor, Model 861290

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218950. Last updated year: 2026. Please use registration number 1218950 when referencing this establishment in official correspondence.
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