The following data is part of a premarket notification filed by Orthoscan, Inc. with the FDA for Orthoscan Fd Mini C-arm.
| Device ID | K133174 |
| 510k Number | K133174 |
| Device Name: | ORTHOSCAN FD MINI C-ARM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | ORTHOSCAN, INC. 8212 E Evans Rd 8224 E Evans Rd Scottsdale, AZ 85260 |
| Contact | Adam Menzies |
| Correspondent | Adam Menzies ORTHOSCAN, INC. 8212 E Evans Rd 8224 E Evans Rd Scottsdale, AZ 85260 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B22510000004FD0 | K133174 | 000 |