2 devices · 1 company · 2023
Nobel Biocare AB: AI-enabled devices on FDA's list
2 devices from Nobel Biocare AB, 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 (1 of 2 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Nobel Biocare AB
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| DTX Studio ClinicK231898 · 510(k) | Radiology | LLZ | database entry | |
| DTX Studio Clinic 3.0K221921 · 510(k) | Radiology | MYN | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.