Company ยท US
Philips Healthcare Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2015. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
170recalls (0 in 12 months)
157recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQA | Oximeter | 25 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 21 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 19 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 13 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 12 |
| JAK | System, X-Ray, Tomography, Computed | 10 |
| KPR | System, X-Ray, Stationary | 10 |
| OWB | Interventional Fluoroscopic X-Ray System | 7 |
| HGM | System, Monitoring, Perinatal | 6 |
| IZI | System, X-Ray, Angiographic | 6 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 6 |
| DXJ | Display, Cathode-Ray Tube, Medical | 5 |
| BSZ | Gas-Machine, Anesthesia | 4 |
| IZL | System, X-Ray, Mobile | 4 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 4 |
| BZC | Calculator, Pulmonary Function Data | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
| IXR | Table, Radiographic, Tilting | 2 |
| LLZ | System, Image Processing, Radiological | 2 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2023 | Philips Healthcare Incisive CT, software version 5.0 Open, Classified |
JAK | K180015 K211168 +1 |
| Feb 2, 2022 | Philips Healthcare Philips StentBoost Live R2.0 application, when used with the
Philips Azurion with software release R2.x Terminated |
OWB | K200917 |
| Sep 24, 2021 | Philips Healthcare Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) Open, Classified |
OWB | K200917 |
| Sep 22, 2021 | Philips Healthcare CombiDiagnost R90 is multi-functional general R/F systems. Open, Classified |
JAA | K203087 |
| Sep 22, 2021 | Philips Healthcare ProxiDiagnost N90 is multi-functional general R/F systems. Open, Classified |
OWB | K173433 |
| Sep 22, 2021 | Philips Healthcare DigitalDiagnost C90 Open, Classified |
MQB | K202564 |
| May 26, 2021 | Philips Healthcare Azurion systems with software release R2.0.x Completed |
OWB | K200917 |
| Dec 21, 2018 | Philips Healthcare DigitalDiagnost C50, Stationary X-ray System Terminated |
KPR | K163410 |
| Jun 11, 2018 | Philips Healthcare Centron
Product Usage:
Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications includin Terminated |
OWB | None listed |
| Jun 11, 2018 | Philips Healthcare UNIQ
Product Usage:
Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including d Terminated |
OWB | None listed |
| Jun 11, 2018 | Philips Healthcare Allura Xper
Product Usage:
Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications incl Terminated |
OWB | None listed |
| Jun 3, 2016 | Philips Healthcare Philips Healthcare DuraDiagnost stationary X-ray system Terminated |
KPR | K141381 |
| Jun 3, 2016 | Philips Healthcare Philips Healthcare DigitalDiagnost stationary X-ray system Terminated |
MQB | K141736 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Terminated |
JAK | K033326 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Terminated |
JAK | K033326 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Terminated |
JAK | K033326 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Terminated |
JAK | K033326 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Terminated |
JAK | K060937 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Terminated |
JAK | K060937 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Terminated |
JAK | K060937 |
| Jun 11, 2014 | Philips Healthcare Inc. Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor. Terminated |
MHX | K102495 |
| Jan 27, 2014 | Philips Healthcare InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V).
Product Usage:
The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hy Terminated |
NCX | K080908 |
| Aug 26, 2013 | Philips Healthcare Inc. Philips Easy Upgrade DR, Code No: 712086
This system is used for making X-Ray exposures for diagnostics. Terminated |
KPR | K982795 |
| Aug 21, 2013 | Philips Healthcare Inc. Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System
Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qual Terminated |
IZL | K111725 |
| Jul 24, 2013 | Philips Healthcare Inc. Philips HeartStart MRx Monitor/Defibrillator,
Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
The device is for use by qualified medical personnel trained i Terminated |
MKJ | K051134 |
| Jul 20, 2013 | Philips Healthcare Inc. Radiohead Access Point 1.4 GHz Radiohead Access Point
Firmware versions: C.00.04 & C.00.05
Part Number: 989803171211
Product Usage:
IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless Terminated |
MHX | K041741 |
| Jun 17, 2013 | Philips Healthcare Inc. Philips Diagnost Stationary Radiographic System
Models:
712020, 712022, 712050, 712052, 712055, 712057, 712062
Product Usage:
Universal RAD Applications Terminated |
MQB | K982795 |
| Jun 17, 2013 | Philips Healthcare Inc. Philips Diagnost Stationary Radiographic System
Models:
712020, 712022, 712050, 712052, 712055, 712057, 712062
Product Usage:
Universal RAD Applications Terminated |
MQB | K982795 |
| Jun 17, 2013 | Philips Healthcare Inc. Philips BuckyDiagnost Radiographic.
Catalog Numbers:
704031, 704032, 704035, 704060, 704062
This system is used for making x-ray exposures for diagnostics Terminated |
KPR | K945278 |
| Jun 17, 2013 | Philips Healthcare Inc. Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system.
Catalog Numbers:
704031, 704032, 704035, 704060, 704062
This system is used for making x-ray exposures for diagnostics. Terminated |
KPR | K945278 |
| Apr 29, 2013 | Philips Healthcare Inc. HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6.
The HeartStart MRx is for use for the termination of ventricular tachycardi Terminated |
MKJ | K051134 |
| Apr 17, 2013 | Philips Healthcare Inc. Philips Healthcare Computed Tomography X-Ray System.
These devices are whole-body computed tomography (CT) x-ray
systems or sub-systems, each with a continuously rotating x-ray tube
and multi-row det Terminated |
JAK | None listed |
| Mar 1, 2013 | Philips Healthcare Inc. Philips Digital Diagnost
Stationary radiographic system Terminated |
MQB | K982795 |
| Feb 26, 2013 | Philips Healthcare Inc. Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3
Model numbers 712020, 712022, and 712082
Product Usage:
Digital radiographic system Terminated |
MQB | K982795 |
| Feb 21, 2013 | Philips Healthcare Inc. Philips HeartStart XL+ Defibrillator/Monitor
Model number: 861290
The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device a Terminated |
MKJ | K110825 |
| Feb 14, 2013 | Philips Healthcare Inc. Philips Healthcare SureSigns VS2+
Model 863278 SureSigns VS2+ NBP and SpO2
Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature
Product Usage:
The SureSigns VS2+ vital signs monitor is for monitorin Terminated |
DXN | K112652 |
| Feb 1, 2013 | Philips Healthcare Inc. Phillips Easy Diagnost Eleva DRF. Model Number: 706034
Product Usage:
Universal Fluoroscopic Applications Terminated |
KPR | K031535 |
| Jan 28, 2013 | Philips Healthcare Inc. Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose
Model: 70920
Product Usage:
Universal R/F, general use Terminated |
RCA | K050190 |
| Dec 10, 2012 | Philips Healthcare Inc. Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX
The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, Terminated |
MHX | K081983 K102495 |
| Dec 5, 2012 | Philips Healthcare Inc. Philips Digital Diagnost Software Version R2.0.2
Product Usage:
This system is used for making X-ray exposures for diagnostics Terminated |
MQB | K982795 |
| Nov 28, 2012 | Philips Healthcare Inc. Mobile Diagnostic X-Ray System with Digital Panel Terminated |
IZL | K111725 |
| Oct 4, 2012 | Philips Healthcare Inc. 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 Terminated |
MKJ | K021453 |
| Sep 28, 2012 | Philips Healthcare Inc. Philips Digital Diagnost with patient carriage
Model: 712050 with serial number range from 00 000 00 to 09 000 543.
Product Usage:
Stationary radiographic System Terminated |
MQB | K982795 |
| Sep 27, 2012 | Philips Healthcare Inc. Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3)
System codes: 712020, 712022, 712025
This system is used for making X-ray exposures fo Terminated |
MQB | K982795 |
| Sep 14, 2012 | Philips Healthcare Inc. Philips DigitalDiagnost Systems with M Cabinet
Model: 712025
Stationary radiographic system, digital-Universal RAD Applications Terminated |
MQB | K982795 |
| Sep 10, 2012 | Philips Healthcare Inc. Philips HeartStart MRx monitor/defibrillators
Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6
The Heartstart MRx is for use for the terminatio Terminated |
MKJ | K051134 |
| Aug 30, 2012 | Philips Healthcare Inc. Philips SureSigns VSi/VS2+ patient monitors
Model Part Numbers
VSi/ 863275, 863276, 863277,
VS2+ 863278, 863279.
The SureSigns VS2+ vital signs monitor is for monitoring, recording and Terminated |
DXN | K112652 |
| Aug 15, 2012 | Philips Healthcare Inc. Philips Essenta DR, X-Ray System, Diagnostic, general-purpose
Model: 712070.
The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation Terminated |
KPR | K070528 |
| Aug 15, 2012 | Philips Healthcare Inc. Philips Easy Diagnost Classic-Stationary x-ray system
Catalog Numbers: 70642, 70643, 706030, 706031, 706032
Stationary x-ray system, Universal RF system for general use. Terminated |
IXR | K031535 K970640 |
| Aug 8, 2012 | Philips Healthcare Inc. Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034
Product Usage:
Philips X-ray System Terminated |
KPR | K050151 |
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