9 devices · 9 companies · 2011 to 2026
AI-enabled general and plastic surgery devices on FDA's list
9 devices in the General and Plastic Surgery panel, 2011 to 2026, from 9 companies across 8 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 9 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the General and Plastic Surgery panel
- PZP · Fluid Jet Removal System2
- SHY · Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.1
- SHH · Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer1
- QZB · Software Controlled Endoscope And Instrument Holder1
- QZS · Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer1
- ONV · Electrical Impedance Spectrometer1
- OEE · Diagnostic Low Electric Field1
- OYD · Optical Diagnostic Device For Melanoma Detection1
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| DeepView AI SystemDEN250028 · De Novo | spectralmd, inc. | SHY | database entry | |
| Claire OCT SystemP250008 · PMA | Perimeter Medical Imaging Ai, Inc. | SHH | database entry | |
| HYDROS Robotic SystemK251082 · 510(k) | Procept Biorobotics | PZP | database entry | |
| Maestro SystemK242323 · 510(k) | Moon Surgical | QZB | database entry | |
| HYDROS Robotic SystemK240200 · 510(k) | Procept BioRobotics | PZP | database entry | |
| DermaSensorDEN230008 · De Novo | DermaSensor Inc. | QZS | database entry | |
| NEVISENSEP150046 · PMA | SCIBASE AB | ONV | database entry | |
| DUNE MEDICAL DEVICES MARGINPROBE SYSTEMP110014 · PMA | Dilon Medical Technologies, Ltd. | OEE | database entry | |
| MELAFINDP090012 · PMA | STRATA SKIN SCIENCES, INC. | OYD | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.