3 devices · 1 company · 2021 to 2023
Olea Medical: AI-enabled devices on FDA's list
3 devices from Olea Medical, 2021 to 2023, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Olea Medical
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| MR DWI/FLAIR Measurement V1.0K230552 · 510(k) | Radiology | LLZ | database entry | |
| MR Diffusion Perfusion Mismatch V1.0K223502 · 510(k) | Radiology | LLZ | database entry | |
| breastscape v1.0K211431 · 510(k) | Radiology | QIH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.