# Philips India Limited - Image Guided Therapy Systems Business Unit (specification developer, Pune Maharashtra, IN): 3 new FDA device listings, incl. interventional fluoroscopic x-ray system

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Philips India Limited - Image Guided Therapy Systems Business Unit |
| Owner / operator | Philips Medical Systems International BV |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Pune Maharashtra, IN |
| New listings | 3 |
| Devices | Interventional Fluoroscopic X-Ray System; System, X-Ray, Fluoroscopic, Image-Intensified; Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Product codes | OWB, JAA, OXO |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | Zenition 30 |
| First new listing | 2026-08-13 |
| Latest new listing | 2026-08-13 |
| FDA registration number | 3033525987 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.