The following data is part of a premarket notification filed by Orthoscan, Inc. with the FDA for Orthoscan Mobile Di Mini C-arm.
| Device ID | K113708 |
| 510k Number | K113708 |
| Device Name: | ORTHOSCAN MOBILE DI MINI C-ARM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | ORTHOSCAN, INC. 8212 E. EVANS ROAD Scottsdale, AZ 85260 |
| Contact | Chris Eaves |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B225100000050 | K113708 | 000 |