9 devices · 2 companies · 2018 to 2021
Zebra Medical Vision Ltd.: AI-enabled devices on FDA's list
9 devices from Zebra Medical Vision Ltd., 2018 to 2021, from 2 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 9 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Zebra Medical Vision Ltd.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| HealthPPTK211803 · 510(k) | Radiology | QFM | database entry | |
| HealthCCSngK210085 · 510(k) | Radiology | JAK | database entry | |
| HealthJOINTK202487 · 510(k) | Radiology | LLZ | database entry | |
| HealthMammoK200905 · 510(k) | Radiology | QFM | database entry | |
| HealthVCFK192901 · 510(k) | Radiology | QFM | database entry | |
| HealthCXRK192320 · 510(k) | Radiology | QFM | database entry | |
| HealthICHK190424 · 510(k) | Radiology | QAS | database entry | |
| HealthPNXK190362 · 510(k) | Radiology | QFM | database entry | |
| HealthCCSK172983 · 510(k) | Radiology | JAK | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.