Medical Device Manufacturer · US , Seneca , SC

Philips Medical Systems Dmc GmbH

18 submissions · 18 cleared · Since 2013
18
Total
18
Cleared
0
Denied

Philips Medical Systems Dmc GmbH — FDA 510(k) Submissions

Philips Medical Systems Dmc GmbH has submitted 18 FDA 510(k) premarket notifications since 2013, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Solid State X-ray Imager (flat Panel/digital Imager), System, X-ray, Fluoroscopic, Image-intensified, System, X-ray, Stationary, Interventional Fluoroscopic X-ray System, System, X-ray, Mobile . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
Radiography 7300 C
K233662 · KPR System, X-ray, Stationary · Radiology
Jun 2024 211d
Radiography 7000 M
K233678 · IZL System, X-ray, Mobile · Radiology
Feb 2024 90d
ProxiDiagnost N90 / Precision CRF (706110, 706400)
K233945 · JAA System, X-ray,... · Radiology
Jan 2024 28d
CombiDiagnost R90
K232910 · JAA System, X-ray,... · Radiology
Oct 2023 30d
Philips Radiology Smart Assistant
K212186 · KPR System, X-ray, Stationary · Radiology
Dec 2021 153d
ProxiDiagnost N90
K212837 · JAA System, X-ray,... · Radiology
Sep 2021 14d
DigitalDiagnost
K210692 · KPR System, X-ray, Stationary · Radiology
Apr 2021 25d
CombiDiagnost R90
K203087 · JAA System, X-ray,... · Radiology
Dec 2020 51d
DigitalDiagnost C90
K202564 · MQB Solid State X-ray Imager... · Radiology
Sep 2020 26d
DigitalDiagnost C90
K182973 · MQB Solid State X-ray Imager... · Radiology
Jan 2019 77d
ProxiDiagnost N90
K173433 · OWB Interventional... · Radiology
Feb 2018 95d
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
K171461 · MQB Solid State X-ray Imager... · Radiology
Jul 2017 50d
pixium 4343RCE
K170113 · MQB Solid State X-ray Imager... · Radiology
Feb 2017 28d
Philips CombiDiagnost R90
K163210 · JAA System, X-ray,... · Radiology
Jan 2017 77d
Philips Eleva Workspot with SkyFlow
K153318 · MQB Solid State X-ray Imager... · Radiology
Dec 2015 34d
PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
K141736 · MQB Solid State X-ray Imager... · Radiology
Jul 2014 28d
PHILIPS ELEVA WORKSPOT
K140771 · MQB Solid State X-ray Imager... · Radiology
Apr 2014 29d
PHILIPS PIXIUM 4343RC
K131483 · MQB Solid State X-ray Imager... · Radiology
Oct 2013 137d
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