Company
Philips Electronics North America Corporation
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
163recalls (0 in 12 months)
149recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | 40 |
| IZI | System, X-Ray, Angiographic | 34 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 22 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 16 |
| JAK | System, X-Ray, Tomography, Computed | 12 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 11 |
| DSI | Detector And Alarm, Arrhythmia | 6 |
| KPR | System, X-Ray, Stationary | 4 |
| IMD | Pack, Hot Or Cold, Disposable | 3 |
| IZF | System, X-Ray, Tomographic | 3 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 3 |
| LIX | Aid, Cardiopulmonary Resuscitation | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| IXR | Table, Radiographic, Tilting | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
| OUG | Medical Device Data System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2018 | Philips Electronics North America Corporation Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 Terminated |
DQK | K101571 |
| Oct 10, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological par Open, Classified |
DSI | K113125 |
| Oct 10, 2018 | Philips Electronics North America Corp. Philips HeartStart FR3 Defibrillator, Model: 861388, 861389
Product Usage:
The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden card Terminated |
MKJ | None listed |
| Sep 21, 2018 | Philips Electronics North America Corporation Cesar Powerpack-Visub(V3000), System Code 72243
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZF | K925302 |
| Sep 21, 2018 | Philips Electronics North America Corporation Cesar-DMCP-Visub(HM2000/3000), System Code 72239
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZF | K925302 |
| Sep 21, 2018 | Philips Electronics North America Corporation Poly C- DMCP-Visub(H3000), System Code 72238
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZF | K925302 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F020 Biplane DR Table, System Code 722020
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F010/10 DRTable, System Code 722019
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F020 DR Table, System Code 722015
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F010 DR Table, System Code 722014
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F020 DR Table, System Code 722023
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation AIIura Xper F010 DR Table, System Code 722022
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
OWB | K141979 |
| Sep 21, 2018 | Philips Electronics North America Corporation AIIuraXperFDlO/10, System Code 722011
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K041949 |
| Sep 21, 2018 | Philips Electronics North America Corporation AIIuraXperFDlO, System Code 722010
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K041949 |
| Sep 21, 2018 | Philips Electronics North America Corporation AlluraXperFOlO/lO, System Code 722005
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K041949 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper F010, System Code 722003
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K041949 |
| Sep 21, 2018 | Philips Electronics North America Corporation AlIura Xper F010 F, System Code 722002
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K041949 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper FD1O C, System Code 722001
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K041949 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper FD2O Biplane, System Code 722008
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K033737 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper FD2O Biplane, System Code 722013
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K033737 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper FD2O, System Code 722012
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K033737 |
| Sep 21, 2018 | Philips Electronics North America Corporation Allura Xper FD2O, System Code 722006
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K033737 |
| Sep 21, 2018 | Philips Electronics North America Corporation NTEGRIS Allura 9 0 FDXD, System Code 722498
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 9 F FDXD, System Code 722497
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS SUITE, System Code 722199
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 15-12 (biplane), System Code 722044
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 15-12 (mono), System Code 722043
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS CV, System Code 722030
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 9 (biplane), System Code 722021
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Sep 21, 2018 | Philips Electronics North America Corporation INTEGRIS Allura 9, System Code 722018
Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions Terminated |
IZI | K031333 |
| Jul 13, 2018 | Philips Electronics North America Corporation Philips SureSigns VS2 monitor, 863079
863080
863081
863082
863283
863286
The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the phy Open, Classified |
MHX | K090483 |
| Jul 13, 2018 | Philips Electronics North America Corporation Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063
863064
863065
863066
863068
863077
863085
863086
863317
863287
863288
863289
The SureSigns VM4, VM6, and VM8 patient monitors are for use by hea Open, Classified |
MHX | K080495 K123900 |
| Jul 13, 2018 | Philips Electronics North America Corporation Philips SureSigns VS4 Vital Signs Monitor, 863283
863286
The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parame Open, Classified |
MHX | K163649 |
| Jul 13, 2018 | Philips Electronics North America Corporation Philips SureSigns VS3 Vital Signs Monitor, 863069
863070
863071
863072
863073
863074
The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults Open, Classified |
MHX | K163649 |
| Jul 13, 2018 | Philips Electronics North America Corporation Philips SureSigns VSV (Vital Signs Viewer), 863067
Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia o Open, Classified |
MHX | K070588 |
| May 3, 2018 | Philips Electronics North America Corporation HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289)
Product Automated external defibrillators (non-wearable)
Product Usage:
The HeartStart MRx is for use for the termina Terminated |
MKJ | K063375 |
| Apr 30, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146 Terminated |
DSI | K113125 |
| Apr 30, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352 Terminated |
DSI | K113125 |
| Apr 30, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351 Terminated |
DSI | K113125 |
| Apr 30, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350 Terminated |
DSI | K113125 |
| Apr 18, 2018 | Philips Electronics North America Corporation T5 Model 78104
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the Terminated |
LNH | K890789 |
| Apr 18, 2018 | Philips Electronics North America Corporation Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation T10-NT, Model 78107
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of Terminated |
LNH | K945945 |
| Apr 18, 2018 | Philips Electronics North America Corporation ACS-NT, Model 78108
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of Terminated |
LNH | K945945 |
| Apr 18, 2018 | Philips Electronics North America Corporation T5-NT, Model 78104
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of Terminated |
LNH | K945945 |
| Apr 18, 2018 | Philips Electronics North America Corporation Ingenia 1.5T CX, Models 781261 & 781262
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the i Terminated |
LNH | K162931 |
| Apr 18, 2018 | Philips Electronics North America Corporation Conversion SmarthPath to dStream for 1.5T, Model 781260
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orie Terminated |
LNH | K162931 |
| Apr 18, 2018 | Philips Electronics North America Corporation Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) A Terminated |
LNH | K052013 |
| Apr 18, 2018 | Philips Electronics North America Corporation Panorama 1.0T, Model 781250
Product Usage:
Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal stru Terminated |
LNH | K041602 |
| Apr 18, 2018 | Philips Electronics North America Corporation Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4)
Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explore Terminated |
LNH | K052013 |
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