2 devices · 2 companies · 2017 to 2026
spectralmd, inc.: AI-enabled devices on FDA's list
2 devices from spectralmd, inc., 2017 to 2026, from 2 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from spectralmd, inc.
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| DeepView AI SystemDEN250028 · De Novo | General and Plastic Surgery | SHY | database entry | |
| SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0K163339 · 510(k) | Cardiovascular | DPT | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.