18 devices · 17 companies · 2016
AI-enabled medical devices FDA authorized in 2016
18 devices authorized in 2016, 2016, from 17 companies across 10 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (17 of 18 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2016
- LLZ · System, Image Processing, Radiological7
- DQD · Stethoscope, Electronic2
- PJA · Coronary Vascular Physiologic Simulation Software2
- NBW · System, Test, Blood Glucose, Over The Counter1
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic1
- MYN · Analyzer, Medical Image1
- PIW · Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid1
- OEB · Lung Computed Tomography System, Computer-Aided Detection1
- PBZ · Image Processing Device For Estimation Of External Blood Loss1
- OWB · Interventional Fluoroscopic X-Ray System1
Panels
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | Product code | FDA |
|---|---|---|---|---|---|
| ClearView cCADK161959 · 510(k) | ClearView Diagnostics Inc. | Radiology | LLZ | database entry | |
| CT CoPilotK161322 · 510(k) | ZEPMED, LLC. | Radiology | LLZ | database entry | |
| One Drop Blood Glucose Monitoring SystemK161834 · 510(k) | AgaMatrix, Inc. | Clinical Chemistry | NBW | database entry | |
| Clarius Ultrasound SystemK163138 · 510(k) | Clarius Mobile Health Corp. | Radiology | IYN | database entry | |
| QVCAD SystemP150043 · PMA | QView Medical, Inc. | Radiology | MYN | database entry | |
| Tyto StethoscopeK160401 · 510(k) | Tyto Care Ltd. | Cardiovascular | DQD | database entry | |
| Ahead 300K161068 · 510(k) | BRAINSCOPE COMPANY INC | Neurology | PIW | database entry | |
| PixelShineK161625 · 510(k) | ALGOMEDICA | Radiology | LLZ | database entry | |
| ClearRead CTK161201 · 510(k) | RIVERAIN TECHNOLOGIES, LLC | Radiology | OEB | database entry | |
| FFRctK161772 · 510(k) | HEARTFLOW, INC. | Cardiovascular | PJA | database entry | |
| icobrainK161148 · 510(k) | Icometrix | Radiology | LLZ | database entry | |
| Triton SystemK160338 · 510(k) | GAUSS SURGICAL INC. | General Hospital | PBZ | database entry | |
| LVivo Software ApplicationK161382 · 510(k) | DIACARDIO, LTD. | Radiology | LLZ | database entry | |
| Steth IOK160016 · 510(k) | STRATOSCIENTIFIC, INC. | Cardiovascular | DQD | database entry | |
| Cydar EVK160088 · 510(k) | Cydar Ltd. | Radiology | OWB | database entry | |
| Quantib Brain 1K153351 · 510(k) | QUANTIB BV | Radiology | LLZ | database entry | |
| FFRctK152733 · 510(k) | HEARTFLOW, INC. | Cardiovascular | PJA | database entry | |
| Volpara Imaging SoftwareK153427 · 510(k) | Matakina Technology LTD | Radiology | LLZ | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.