10 devices · 4 companies · 2020 to 2025
Coreline Soft Co.,Ltd: AI-enabled devices on FDA's list
10 devices from Coreline Soft Co.,Ltd, 2020 to 2025, from 4 companies across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (9 of 10 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Coreline Soft Co.,Ltd
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| AVIEW Lung Nodule CADK251203 · 510(k) | Radiology | OEB | database entry | |
| AVIEWK243689 · 510(k) | Radiology | QIH | database entry | |
| AVIEW CACK243696 · 510(k) | Radiology | QIH | database entry | |
| AVIEW CACK233211 · 510(k) | Radiology | QIH | database entry | |
| AVIEW Lung Nodule CADK221592 · 510(k) | Radiology | OEB | database entry | |
| AVIEWK214036 · 510(k) | Radiology | QIH | database entry | |
| AVIEW RT ACSK220408 · 510(k) | Radiology | QKB | database entry | |
| A View LCSK201710 · 510(k) | Radiology | LLZ | database entry | |
| AVIEWK200714 · 510(k) | Radiology | LLZ | database entry | |
| AVIEW LCSK193220 · 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.