Data / Medical devices / India / Niramai Health Analytix
Niramai Health Analytix: FDA-registered device maker in Bangalore Karnataka, India, 1 510(k) clearance
Niramai Health Analytix is registered with the FDA (registration 3018553169) in Bangalore Karnataka, India. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 10, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018553169
- Address
- Niramai Health Analytix Pvt Ltd Innova Pearl, No. 17, 5th Block, Koramangala, Bangalore Karnataka, India, 560095
- Owner or operator
- NIRAMAI Health Analytix Pvt Ltd (10086919)
- Roles
- Manufacturer
- First device listed
- December 22, 2022
- Registered through
- 2026
- Brand names listed
- BreastHealth-100, MammoBuddy, SMILE-100 System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Telethermographic (Adjunctive Use) | LHQ | 1 | 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 |
|---|---|---|---|---|---|---|
| March 10, 2022 | K212965 | Smile-100 System | LHQ | Substantially Equivalent | Niramai Health Analytix Private Limited | accessdata.fda.gov |
Compare with other makers
Updated March 10, 2022. 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.