12 devices · 1 company · 2016 to 2026
Clarius Mobile Health Corp.: AI-enabled devices on FDA's list
12 devices from Clarius Mobile Health Corp., 2016 to 2026, 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 (12 of 12 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Clarius Mobile Health Corp.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Clarius Ejection Fraction AIK253593 · 510(k) | Radiology | QIH | database entry | |
| Clarius Median Nerve AIK250226 · 510(k) | Radiology | QIH | database entry | |
| Clarius Prostate AIK243853 · 510(k) | Radiology | QIH | database entry | |
| Clarius OB AIK233955 · 510(k) | Radiology | IYN | database entry | |
| Clarius Bladder AIK232257 · 510(k) | Radiology | QIH | database entry | |
| Clarius Ultrasound ScannerK232704 · 510(k) | Radiology | IYN | database entry | |
| Clarius AIK222406 · 510(k) | Radiology | QIH | database entry | |
| Clarius Ultrasound ScannerK213436 · 510(k) | Radiology | IYN | database entry | |
| Clarius Ultrasound ScannerK192107 · 510(k) | Radiology | IYN | database entry | |
| Clarius Ultrasound ScannerK180799 · 510(k) | Radiology | IYN | database entry | |
| Clarius Ultrasound SystemK172385 · 510(k) | Radiology | IYN | database entry | |
| Clarius Ultrasound SystemK163138 · 510(k) | Radiology | IYN | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.