ClearanceBrief
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

CodeDeviceRecords
DQAOximeter25
MKJAutomated External Defibrillators (Non-Wearable)21
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase19
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)13
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)12
JAKSystem, X-Ray, Tomography, Computed10
KPRSystem, X-Ray, Stationary10
OWBInterventional Fluoroscopic X-Ray System7
HGMSystem, Monitoring, Perinatal6
IZISystem, X-Ray, Angiographic6
JAASystem, X-Ray, Fluoroscopic, Image-Intensified6
DXJDisplay, Cathode-Ray Tube, Medical5
BSZGas-Machine, Anesthesia4
IZLSystem, X-Ray, Mobile4
LKDMonitor, Carbon-Dioxide, Cutaneous4
BZCCalculator, Pulmonary Function Data3
DSIDetector And Alarm, Arrhythmia2
DXNSystem, Measurement, Blood-Pressure, Non-Invasive2
IXRTable, Radiographic, Tilting2
LLZSystem, Image Processing, Radiological2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 30, 2015K152899Philips Lumify Diagnostic Ultrasound System
Philips Healthcare, Inc.
IYN

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 30, 2023Philips Healthcare
Incisive CT, software version 5.0
Open, Classified
JAKK180015
K211168 +1
Feb 2, 2022Philips Healthcare
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Terminated
OWBK200917
Sep 24, 2021Philips Healthcare
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Open, Classified
OWBK200917
Sep 22, 2021Philips Healthcare
CombiDiagnost R90 is multi-functional general R/F systems.
Open, Classified
JAAK203087
Sep 22, 2021Philips Healthcare
ProxiDiagnost N90 is multi-functional general R/F systems.
Open, Classified
OWBK173433
Sep 22, 2021Philips Healthcare
DigitalDiagnost C90
Open, Classified
MQBK202564
May 26, 2021Philips Healthcare
Azurion systems with software release R2.0.x
Completed
OWBK200917
Dec 21, 2018Philips Healthcare
DigitalDiagnost C50, Stationary X-ray System
Terminated
KPRK163410
Jun 11, 2018Philips Healthcare
Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications includin
Terminated
OWBNone listed
Jun 11, 2018Philips Healthcare
UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including d
Terminated
OWBNone listed
Jun 11, 2018Philips Healthcare
Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications incl
Terminated
OWBNone listed
Jun 3, 2016Philips Healthcare
Philips Healthcare DuraDiagnost stationary X-ray system
Terminated
KPRK141381
Jun 3, 2016Philips Healthcare
Philips Healthcare DigitalDiagnost stationary X-ray system
Terminated
MQBK141736
Sep 6, 2015Philips Healthcare
Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
Terminated
JAKK033326
Sep 6, 2015Philips Healthcare
Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
Terminated
JAKK033326
Sep 6, 2015Philips Healthcare
Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
Terminated
JAKK033326
Sep 6, 2015Philips Healthcare
Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
Terminated
JAKK033326
Sep 6, 2015Philips Healthcare
Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
Terminated
JAKK060937
Sep 6, 2015Philips Healthcare
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Terminated
JAKK060937
Sep 6, 2015Philips Healthcare
Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
Terminated
JAKK060937
Jun 11, 2014Philips 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
MHXK102495
Jan 27, 2014Philips 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
NCXK080908
Aug 26, 2013Philips Healthcare Inc.
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
Terminated
KPRK982795
Aug 21, 2013Philips 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
IZLK111725
Jul 24, 2013Philips 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
MKJK051134
Jul 20, 2013Philips 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
MHXK041741
Jun 17, 2013Philips Healthcare Inc.
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Terminated
MQBK982795
Jun 17, 2013Philips Healthcare Inc.
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
Terminated
MQBK982795
Jun 17, 2013Philips Healthcare Inc.
Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
Terminated
KPRK945278
Jun 17, 2013Philips 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
KPRK945278
Apr 29, 2013Philips 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
MKJK051134
Apr 17, 2013Philips 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
JAKNone listed
Mar 1, 2013Philips Healthcare Inc.
Philips Digital Diagnost Stationary radiographic system
Terminated
MQBK982795
Feb 26, 2013Philips 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
MQBK982795
Feb 21, 2013Philips 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
MKJK110825
Feb 14, 2013Philips 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
DXNK112652
Feb 1, 2013Philips Healthcare Inc.
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
Terminated
KPRK031535
Jan 28, 2013Philips Healthcare Inc.
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
Terminated
RCAK050190
Dec 10, 2012Philips 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
MHXK081983
K102495
Dec 5, 2012Philips Healthcare Inc.
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Terminated
MQBK982795
Nov 28, 2012Philips Healthcare Inc.
Mobile Diagnostic X-Ray System with Digital Panel
Terminated
IZLK111725
Oct 4, 2012Philips 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
MKJK021453
Sep 28, 2012Philips 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
MQBK982795
Sep 27, 2012Philips 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
MQBK982795
Sep 14, 2012Philips Healthcare Inc.
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
Terminated
MQBK982795
Sep 10, 2012Philips 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
MKJK051134
Aug 30, 2012Philips 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
DXNK112652
Aug 15, 2012Philips 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
KPRK070528
Aug 15, 2012Philips 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
IXRK031535
K970640
Aug 8, 2012Philips Healthcare Inc.
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
Terminated
KPRK050151

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