SURGIMAGE SIM 1000H Fluorescence Imaging Platform
Device Facts
| Record ID | K253181 |
|---|---|
| Device Name | SURGIMAGE SIM 1000H Fluorescence Imaging Platform |
| Applicant | Surgimage Corporation |
| Product Code | IZI · Radiology |
| Decision Date | May 13, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
