7 devices · 1 company · 2017 to 2024
Surgical Information Sciences, Inc.: AI-enabled devices on FDA's list
7 devices from Surgical Information Sciences, Inc., 2017 to 2024, 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 (7 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Surgical Information Sciences, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| SIS SystemK241083 · 510(k) | Radiology | QIH | database entry | |
| SIS SystemK230977 · 510(k) | Radiology | QIH | database entry | |
| SIS SystemK223032 · 510(k) | Radiology | QIH | database entry | |
| SIS SystemK210071 · 510(k) | Radiology | LLZ | database entry | |
| SIS Software Version 3.6.0K192304 · 510(k) | Radiology | LLZ | database entry | |
| SIS Software version 3.3.0K183019 · 510(k) | Radiology | LLZ | database entry | |
| SIS SoftwareK162830 · 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.