Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Philips Medical Systems Dmc GmbH · Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

50 daysmedian FDA review time
153 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K233662Radiography 7300 CPhilips Medical Systems Dmc GmbH2024-06-132111
K233678Radiography 7000 MPhilips Medical Systems Dmc GmbH2024-02-14900
K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH2024-01-11282
K232910CombiDiagnost R90Philips Medical Systems Dmc GmbH2023-10-19301
K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH2021-12-131530
K212837ProxiDiagnost N90Philips Medical Systems Dmc GmbH2021-09-21145
K210692DigitalDiagnostPhilips Medical Systems Dmc GmbH2021-04-02258
K203087CombiDiagnost R90Philips Medical Systems Dmc GmbH2020-12-03514
K202564DigitalDiagnost C90Philips Medical Systems Dmc GmbH2020-09-30267
K182973DigitalDiagnost C90Philips Medical Systems Dmc GmbH2019-01-11770
K173433ProxiDiagnost N90Philips Medical Systems Dmc GmbH2018-02-05954
K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemPhilips Medical Systems Dmc GmbH2017-07-07500
K170113pixium 4343RCEPhilips Medical Systems Dmc GmbH2017-02-09280
K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH2017-01-31776
K153318Philips Eleva Workspot with SkyFlowPhilips Medical Systems Dmc GmbH2015-12-22340
K141736PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOSPhilips Medical Systems Dmc GmbH2014-07-25282
K140771PHILIPS ELEVA WORKSPOTPhilips Medical Systems Dmc GmbH2014-04-25290
K131483PHILIPS PIXIUM 4343RCPhilips Medical Systems Dmc GmbH2013-10-071370

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda