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Philips Medical Systems DMC GmbH: FDA-registered device maker in Hamburg, Germany, 32 510(k) clearances

Philips Medical Systems DMC GmbH is registered with the FDA (registration 3003768251) in Hamburg, Germany. It lists 20 device types. The FDA files 32 510(k) clearances under its listings, the newest dated June 13, 2024. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Philips Medical Systems DMC GmbH
FDA registration number
3003768251
Address
Roentgenstrasse 24, Hamburg, Germany, 22335
Owner or operator
Philips Medical Systems International BV (1217116)
Roles
Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
First device listed
May 31, 2001
Registered through
2026
Brand names listed
Bucky Diagnost Family, BuckyDiagnost, BuckyDiagnost: TH2, THS, CENTERING LIGHT (OR LASER), CT XS Generator, CT XS Tube, CTR17xx Series, CTR21xx Series and more

Devices it lists

DeviceProduct codeClassRoleSource
Assembly, Tube Housing, X-Ray, DiagnosticITY1Complaint file establishment, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Cassette, Radiographic FilmIXA2Complaint file establishment, Exporter to the USaccessdata.fda.gov
Device, Beam Limiting, X-Ray, DiagnosticKPW2Complaint file establishment, Exporter to the USaccessdata.fda.gov
Device, Spot-FilmIXL2Complaint file establishment, Exporter to the US, Specification developeraccessdata.fda.gov
Full Field Digital, System, X-Ray, MammographicMUE2Complaint file establishmentaccessdata.fda.gov
Generator, High-Voltage, X-Ray, DiagnosticIZO1Complaint file establishment, Manufactureraccessdata.fda.gov
Grid, RadiographicIXJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Holder, Radiographic Cassette, Wall-MountedIXY1Complaint file establishment, Manufactureraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Complaint file establishment, Specification developeraccessdata.fda.gov
Monitor, Patient Position, Light-BeamIWE1Complaint file establishment, Exporter to the USaccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Complaint file establishment, Specification developeraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Complaint file establishment, Specification developeraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Complaint file establishment, Specification developeraccessdata.fda.gov
System, X-Ray, MobileIZL2Complaint file establishment, Specification developeraccessdata.fda.gov
System, X-Ray, StationaryKPR2Complaint file establishment, Specification developeraccessdata.fda.gov
Table, Radiographic, Non-Tilting, PoweredIZZ2Complaint file establishment, Specification developeraccessdata.fda.gov
Table, Radiographic, Stationary TopIXQ2Complaint file establishment, Specification developeraccessdata.fda.gov
Table, Radiographic, TiltingIXR2Complaint file establishment, Specification developeraccessdata.fda.gov
Table, RadiologicKXJ2Complaint file establishment, Exporter to the USaccessdata.fda.gov
Tube Mount, X-Ray, DiagnosticIYB1Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 13, 2024K233662Radiography 7300 CKPRSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
February 14, 2024K233678Radiography 7000 MIZLSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
January 11, 2024K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)JAASubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
October 19, 2023K232910CombiDiagnost R90JAASubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
December 13, 2021K212186Philips Radiology Smart AssistantKPRSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
September 21, 2021K212837ProxiDiagnost N90JAASubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
April 2, 2021K210692DigitalDiagnostKPRSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
December 3, 2020K203087CombiDiagnost R90JAASubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
September 30, 2020K202564DigitalDiagnost C90MQBSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
January 11, 2019K182973DigitalDiagnost C90MQBSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
February 5, 2018K173433ProxiDiagnost N90OWBSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
January 31, 2017K163210Philips CombiDiagnost R90JAASubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
December 22, 2015K153318Philips Eleva Workspot with SkyFlowMQBSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
July 25, 2014K141736PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOSTMQBSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
April 25, 2014K140771PHILIPS ELEVA WORKSPOTMQBSubstantially EquivalentPhilips Medical Systems Dmc GmbHaccessdata.fda.gov
December 13, 2013K130704MICRODOSE SIMUESubstantially EquivalentPhilips Digital Mammography Sweden ABaccessdata.fda.gov
February 1, 2013K123995MICRODOSE SIMUESubstantially EquivalentPhilips Digital Mammography Sweden ABaccessdata.fda.gov
April 19, 2012K120255PHILIPS MICRODOSEMUESubstantially EquivalentPhilips Digital Mammography Sweden ABaccessdata.fda.gov
July 28, 2011K111804INTELLISPACE PACS 4.XLLZSubstantially EquivalentPhilips Healthcare Informatics, Inc.accessdata.fda.gov
April 28, 2011K110025SECTRA MICRODOSE MAMMOGRAPHYMUESubstantially EquivalentSectra Imtec ABaccessdata.fda.gov
January 8, 2010K093355PCR ELEVA 1.2LLZSubstantially EquivalentPhilips Medical Systems, Inc.accessdata.fda.gov
March 9, 2007K070528PHILIPS ESSENTA DRMQBSubstantially EquivalentPhilips Medical Systems GmbH, Dmcaccessdata.fda.gov
March 25, 2005K050190APOLLOKXJSubstantially EquivalentVilla Sistemi Medicali S.P.A.accessdata.fda.gov
June 17, 2003K031535PHILIPS EASYDIAGNOST ELEVAKPRSubstantially EquivalentPhilips Medical Systems North America Co.accessdata.fda.gov
November 24, 1998K982795PHILIPS BUCKY VISIONMQBSubstantially EquivalentPhilips Medical Systems, Inc.accessdata.fda.gov
November 2, 1998K983069PHILIPS DUO DIAGNOSTOWBSubstantially EquivalentPhilips Medical Systems North America, Inc.accessdata.fda.gov
March 21, 1997K970640PHILIPS EASY DIAGNOSTIXRSubstantially EquivalentPhilips Medical Systems North America, Inc.accessdata.fda.gov
December 18, 1996K964124PHILIPS COMPUTED RADIOGRAPHYLLZSubstantially EquivalentPhilips Medical Systems, Inc.accessdata.fda.gov
May 11, 1995K946320R 302KPWSubstantially EquivalentRalco S.R.L.accessdata.fda.gov
December 14, 1994K945278PHILIPS BUCKY DIAGNOST FAMILYKPRSubstantially EquivalentPhilips Medical Systems North America, Inc.accessdata.fda.gov
July 29, 1994K942481FUJI ULTIMA EC-MA CASSETTEIXASubstantially EquivalentFujifilm Medical System U.S.A., Inc.accessdata.fda.gov
October 7, 1993K933650PHILIPS XRG 90 X-RAY GENERATOR SYSTEMIZOSubstantially EquivalentPhilips Medical Systems North America, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
October 1, 202597748Class IIOngoingProxiDiagnost N90; Model Number: 706110Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.accessdata.fda.gov
May 19, 202190490Class IIOngoingProxiDiagnost N90. radiography and fluoroscopy systemFollowing a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection mayaccessdata.fda.gov
July 22, 202088393Class IIOngoingCombiDiagnost R90 Software Version R1.0 and R1.1Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.accessdata.fda.gov
December 19, 201984773Class IITerminatedCombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.accessdata.fda.gov
November 7, 201881706Class IITerminatedStationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray SystemkV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose.accessdata.fda.gov
September 19, 201881310Class IITerminatedPhilips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baselineaccessdata.fda.gov
June 27, 201880577Class IITerminatedDigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.accessdata.fda.gov
March 9, 201261365Not yet classifiedTerminatedPhilips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.Underexposed image due to lag in switching between auxiliariesaccessdata.fda.gov

Compare with other makers

Updated November 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.