Data / Medical devices / System, Image Processing, Radiological / India
FDA-registered makers of System, Image Processing, Radiological in India: 16 establishments
16 establishments in India are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 13 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
- System, Image Processing, Radiological
- Product code
- LLZ
- Country
- India
Makers of System, Image Processing, Radiological in India
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units | Bengaluru Karnataka, India | Complaint file establishment, Manufacturer, Specification developer | 13 | July 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Philips Global Business Services LLP - Ultrasound Business Unit | Baner Pune Maharashtra, India | Specification developer | 9 | September 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Ultrasound Business Unit | Bengaluru Karnataka, India | Specification developer | 9 | September 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medsynaptic Private Ltd. | PUNE Maharashtra, India | Manufacturer | 3 | November 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Image Guided Therapy Systems Business Unit | Bengaluru Karnataka, India | Specification developer | 2 | May 31, 2018 | 0 | 0 | 0 | api.fda.gov |
| Baxter Innovations & Business Solutions Pvt. Ltd. | Bangalore Karnataka, India | Specification developer | 1 | May 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Deeptek Medical Imaging Pvt. Ltd | Pune Maharashtra, India | Complaint file establishment, Manufacturer | 1 | April 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Diagnostic X-ray Business Unit | Bengaluru Karnataka, India | Specification developer | 1 | December 18, 1996 | 0 | 0 | 0 | api.fda.gov |
| Philips India Limited - Diagnostic X-ray Business Unit | Pimpri Maharashtra, India | Specification developer | 1 | December 18, 1996 | 0 | 0 | 0 | api.fda.gov |
| Softlink International Pvt. Ltd. | PUNE Maharashtra, India | Manufacturer | 1 | January 7, 2003 | 0 | 0 | 0 | api.fda.gov |
| Telerad Tech | Bangalore Karnataka, India | Manufacturer | 1 | June 20, 2014 | 0 | 0 | 0 | api.fda.gov |
| WIPRO GE HEALTHCARE PRIVATE Ltd. | BANGALORE Karnataka, India | Specification developer | 1 | March 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| Wipro GE Healthcare Private Ltd. | Bangalore Karnataka, India | Manufacturer | 1 | March 24, 2015 | 0 | 0 | 0 | api.fda.gov |
| Kashmir Surgical Works | AMBALA Haryana, India | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips India Limited | Pune Maharashtra, India | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips India Limited - Image Guided Therapy Systems Business Unit | Pune Maharashtra, India | Specification developer | 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.