Data / Medical devices / India / Softlink International Pvt. Ltd.
Softlink International Pvt. Ltd.: FDA-registered device maker in PUNE Maharashtra, India, 1 510(k) clearance
Softlink International Pvt. Ltd. is registered with the FDA (registration 3003989043) in PUNE Maharashtra, India. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 7, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003989043
- Address
- 2 Anand Park Aundh, PUNE Maharashtra, India, 411007
- Owner or operator
- SOFTLINK INTERNATIONAL PVT.LTD. (9053396)
- Roles
- Manufacturer
- First device listed
- December 19, 2007
- Registered through
- 2026
- Brand names listed
- HCP DICOM Net, Imagine Enterprise PACS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 7, 2003 | K023467 | HCP DICOM NET | LLZ | Substantially Equivalent | Softlink International, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 7, 2003. 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.