Data / Medical devices / India / Medsynaptic Private Ltd.
Medsynaptic Private Ltd.: FDA-registered device maker in PUNE Maharashtra, India, 3 510(k) clearances
Medsynaptic Private Ltd. is registered with the FDA (registration 3004730352) in PUNE Maharashtra, India. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 22, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004730352
- Address
- Mantri Galleria, 5th Floor, Off S B Road Model Colony, Shivajinagar, PUNE Maharashtra, India, 411016
- Owner or operator
- MEDSYNAPTIC PRIVATE, LTD. (9065822)
- Roles
- Manufacturer
- First device listed
- August 12, 2004
- Registered through
- 2026
- Brand names listed
- CardioDoc, MEDSYNAPSE RIS PACS & MEDSYNAPSE VNA, MammoDoc, Medsynapse RIS PACS & Medsynapse VNA, Medsynapse Zero Footprint Viewer, SCANDOC, SCANDOC NON DICOM, SCOPYDOC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| November 22, 2019 | K192508 | Medsynapse Ris Pacs & Medsynapse VNA | LLZ | Substantially Equivalent | Medsynaptic Private, Ltd. | accessdata.fda.gov |
| December 2, 2016 | K163158 | MEDSYNAPSE Zero Footprint Viewer | LLZ | Substantially Equivalent | Medsynaptic Private, Ltd. | accessdata.fda.gov |
| December 2, 2009 | K093247 | MEDSYNAPSE PACS SOFTWARE | LLZ | Substantially Equivalent | Medsynaptic Private, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, Digital Image Communications, Radiological
- All makers of Device, Digital Image Storage, Radiological
Updated November 22, 2019. 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.