6 devices · 5 companies · 2019 to 2025
Terarecon,Inc.: AI-enabled devices on FDA's list
6 devices from Terarecon,Inc., 2019 to 2025, from 5 companies across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 6 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Terarecon,Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| TeraRecon Cardiovascular.Calcification.CTK250288 · 510(k) | Radiology | QIH | database entry | |
| TeraRecon Aorta.CTK243158 · 510(k) | Radiology | QIH | database entry | |
| TeraRecon Cardiac.Chambers.MRK241312 · 510(k) | Radiology | QIH | database entry | |
| TeraRecon NeuroK220349 · 510(k) | Radiology | LLZ | database entry | |
| Neuro.Al AlgorithmK200750 · 510(k) | Radiology | LLZ | database entry | |
| iNtuition-Structural Heart ModuleK191585 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.