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Data / Medical devices / India / Philips India Limited - Diagnostic X-ray Business Unit

Philips India Limited - Diagnostic X-ray Business Unit: FDA-registered device maker in Bengaluru Karnataka, India, 17 510(k) clearances

Philips India Limited - Diagnostic X-ray Business Unit is registered with the FDA (registration 3033527770) in Bengaluru Karnataka, India. It lists 8 device types. The FDA files 17 510(k) clearances under its listings, the newest dated June 13, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3033527770
Address
Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka, Bengaluru Karnataka, India, 560064
Owner or operator
Philips Medical Systems International BV (1217116)
Roles
Specification developer
First device listed
May 31, 2001
Registered through
2026
Brand names listed
CombiDiagnost R90, DigitalDiagnost, DigitalDiagnost C90, DuoDiagnost, EasyDiagnost Eleva, Film and Accessories, PCR Cosima X Eleva, PCR Eleva Corado and more

Devices it lists

DeviceProduct codeClassRoleSource
Device, Spot-FilmIXL2Specification developeraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Specification developeraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Specification developeraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Specification developeraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Specification developeraccessdata.fda.gov
System, X-Ray, MobileIZL2Specification developeraccessdata.fda.gov
System, X-Ray, StationaryKPR2Specification developeraccessdata.fda.gov
Table, Radiographic, TiltingIXR2Specification 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
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
June 17, 2003K031535PHILIPS EASYDIAGNOST ELEVAKPRSubstantially EquivalentPhilips Medical Systems North America Co.accessdata.fda.gov
November 2, 1998K983069PHILIPS DUO DIAGNOSTOWBSubstantially EquivalentPhilips Medical Systems North America, Inc.accessdata.fda.gov
December 18, 1996K964124PHILIPS COMPUTED RADIOGRAPHYLLZSubstantially EquivalentPhilips Medical Systems, Inc.accessdata.fda.gov

Compare with other makers

Updated June 13, 2024. 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.