Data / Medical devices / Interventional Fluoroscopic X-Ray System / India
FDA-registered makers of Interventional Fluoroscopic X-Ray System in India: 6 establishments
6 establishments in India are registered with the FDA to make Interventional Fluoroscopic X-Ray System (product code OWB). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Interventional Fluoroscopic X-Ray System
- Product code
- OWB
- Country
- India
Makers of Interventional Fluoroscopic X-Ray System in India
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Philips India Limited - Image Guided Therapy Systems Business Unit | Bengaluru Karnataka, India | Contract manufacturer, Specification developer | 19 | July 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Image Guided Therapy Systems Business Unit | Pune Maharashtra, India | Specification developer | 9 | August 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Diagnostic X-ray Business Unit | Bengaluru Karnataka, India | Specification developer | 2 | February 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Diagnostic X-ray Business Unit | Pimpri Maharashtra, India | Specification developer | 2 | February 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited | Pune Maharashtra, India | Complaint file establishment, Contract manufacturer, Manufacturer | 1 | April 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Skanray Technologies Limited | Mysore Karnataka, India | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.