Data / Medical devices / India / Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units
Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units: FDA-registered device maker in Bengaluru Karnataka, India, 15 510(k) clearances
Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units is registered with the FDA (registration 3033527273) in Bengaluru Karnataka, India. It lists 4 device types. The FDA files 15 510(k) clearances under its listings, the newest dated March 5, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033527273
- 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
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 21, 2006
- Registered through
- 2026
- Brand names listed
- AV Cardiac CT, AV Cardiovascular Suite, AV Vascular, AV Viewer, Advanced Visualization Workspace V15.X, Advanced Visualization Workspace V16.X, Desktop Diagnostic Viewer, Enterprise Viewer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Specification developer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Specification developer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 5, 2026 | K260169 | AV Cardiac CT | JAK | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 22, 2026 | K253735 | AV Vascular | QIH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 15, 2025 | K250181 | AV Viewer | LLZ | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 24, 2024 | K242512 | ROCC Console | LLZ | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 24, 2024 | K240822 | Image Management V15 | LLZ | Substantially Equivalent | Philips Medical Systems Technologies | accessdata.fda.gov |
| December 6, 2018 | K182926 | IntelliSpace Radiology | LLZ | Substantially Equivalent | Philips Healthcare Informatics, Inc. | accessdata.fda.gov |
| April 11, 2017 | K170580 | Carestream Vue PACS | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| October 18, 2016 | K162025 | IntelliSpace Portal Platform | LLZ | Substantially Equivalent | Philips Medical Systems Nederlands B.V. | accessdata.fda.gov |
| February 12, 2016 | K153103 | CARESTREAM Vue PACS | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| September 21, 2015 | K151774 | CARESTREAM Vue Motion | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| February 6, 2014 | K132824 | CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| October 23, 2012 | K122523 | CARESTREAM VUE PACS | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| October 20, 2011 | K110919 | CARESTREAM PACS | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| May 24, 2011 | K111336 | EBW NM 2.0 | LLZ | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| July 18, 2003 | K032096 | PHILIPS VIEWFORUM 2003 | LLZ | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
- All makers of System, Digital Image Communications, Radiological
- All makers of System, X-Ray, Tomography, Computed
Updated March 5, 2026. 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.