Data / Medical devices / India / Deeptek Medical Imaging Pvt. Ltd
Deeptek Medical Imaging Pvt. Ltd: FDA-registered device maker in Pune Maharashtra, India, 2 510(k) clearances
Deeptek Medical Imaging Pvt. Ltd is registered with the FDA (registration 3038187462) in Pune Maharashtra, India. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 5, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038187462
- Address
- 3rd floor, Ideas to impact, Pallod Farms 3, Baner, Pune, Pune Maharashtra, India, 411045
- Owner or operator
- DeepTek Medical Imaging Pvt. Ltd (10093139)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 4, 2025
- Registered through
- 2026
- Brand names listed
- Augmento, DeepTek CXR Analyzer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 5, 2023 | K231001 | DeepTek CXR Analyzer v1.0 | MYN | Substantially Equivalent | Deeptek Medical Imaging Pvt, Ltd. | accessdata.fda.gov |
| April 11, 2023 | K222781 | Augmento | LLZ | Substantially Equivalent | Deeptek Medical Imaging Private Limited | accessdata.fda.gov |
Compare with other makers
Updated October 5, 2023. 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.