Data / Medical devices / France / Inheart
Inheart: FDA-registered device maker in Pessac Gironde, France, 1 510(k) clearance
Inheart is registered with the FDA (registration 3018302800) in Pessac Gironde, France. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018302800
- Address
- IHU Liryc - Hopital Xavier Arnozan Avenue du Haut Leveque, Pessac Gironde, France, 33600
- Owner or operator
- inHEART (10081210)
- Roles
- Manufacturer
- First device listed
- March 27, 2024
- Registered through
- 2026
- Brand names listed
- inHEART MODELS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | 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 |
|---|---|---|---|---|---|---|
| February 29, 2024 | K231683 | inHEART Models | QIH | Substantially Equivalent | Inheart, Sas | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated February 29, 2024. 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.