Data / Medical devices / India / Philips India Limited - Image Guided Therapy Systems Business Unit
Philips India Limited - Image Guided Therapy Systems Business Unit: FDA-registered device maker in Bengaluru Karnataka, India, 21 510(k) clearances
Philips India Limited - Image Guided Therapy Systems Business Unit is registered with the FDA (registration 3033527282) in Bengaluru Karnataka, India. It lists 6 device types. The FDA files 21 510(k) clearances under its listings, the newest dated July 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3033527282
- 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
- Contract manufacturer, Specification developer
- First device listed
- February 21, 2006
- Registered through
- 2026
- Brand names listed
- 3D Roadmap Rel. 1, 3D-CA, 3D-RA, ALLURACLARITY XPER FD SERIES X-RAY SYSTEM, Allura 3D-CA, Allura 3D-RA Rel. 6, Allura Xper FD series and Allura Xper OR Table series, AneurysmFlow and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Contract manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 2 | Specification developer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| July 10, 2026 | K253670 | SmartCT (R3.0 (L10)) | OWB | Substantially Equivalent | Philips Medical Systems B.V. | accessdata.fda.gov |
| January 16, 2026 | K254186 | Azurion R3.1 | OWB | Substantially Equivalent | Philips Medical Systems B.V. | accessdata.fda.gov |
| October 24, 2025 | K251827 | Azurion R3.1 | OWB | Substantially Equivalent | Philips Medical Systems B.V. | accessdata.fda.gov |
| February 9, 2021 | K201583 | SmartCT R1.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 1, 2020 | K200917 | Azurion R2.1 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 31, 2018 | K181177 | Interventional Workspot | LLZ | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 24, 2017 | K172307 | Dynamic Coronary Roadmap 2.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 7, 2017 | K170144 | StentBoost Live | OWB | Substantially Equivalent | Philips Medical Stystems Nederland BV | accessdata.fda.gov |
| December 2, 2016 | K162859 | Allura Xper FD series and Allura Xper OR Table series | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 25, 2016 | K160455 | AneurysmFlow | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 10, 2016 | K160147 | CT TrueView | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 17, 2015 | K151598 | VesselNavigator Rel. 1.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 30, 2015 | K142273 | EmboGuide | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 9, 2014 | K142126 | EP NAVIGATOR REL. 5.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 10, 2014 | K140138 | HEARTNAVIGATOR RELEASE 2.0 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| October 30, 2013 | K132305 | STENTBOOST REL. 4 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| September 6, 2013 | K130893 | XPERCT REL. 3 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| July 24, 2013 | K131263 | XPERGUIDE | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 28, 2013 | K130638 | ALLURACLARITY XPER FD SERIES X-RAY SYSTEM | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| March 21, 2013 | K121772 | ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| September 27, 2004 | K042334 | ALLURA 3D-CA, RELEASE 1 | LLZ | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, X-Ray, Angiographic
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
Updated July 10, 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.