The following data is part of a premarket notification filed by Skanray Technologies Private Limited with the FDA for Skan-c Mobile C-arm X-ray System - 230v Variant, Skan-c Mobile C-arm X-ray System - 110v Variant.
| Device ID | K170946 |
| 510k Number | K170946 |
| Device Name: | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | Skanray Technologies Private Limited Plot 15-17 Hebbal Industrial Area Mysore, IN 570016 |
| Contact | Mahadevan J. |
| Correspondent | Parul Chansoria Elexes Medical Consulting Pvt Ltd. #6494, Tralee Village Dr. Dr Dublin, CA 94568 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-30 |
| Decision Date | 2017-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08904269405519 | K170946 | 000 |