The following data is part of a premarket notification filed by Orthoscan, Inc. with the FDA for Orthoscan Tau Mini C-arm.
| Device ID | K183220 |
| 510k Number | K183220 |
| Device Name: | OrthoScan TAU Mini C-Arm |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | Orthoscan, Inc. 14555 N. 82nd St. Scottsdale, AZ 85260 |
| Contact | Richard Westrich |
| Correspondent | Steve D Seeman Orthoscan, Inc. 14555 N. 82nd St. Scottsdale, AZ 85260 |
| Product Code | OXO |
| Subsequent Product Code | JAA |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2019-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B225100000170 | K183220 | 000 |
| B225100000160 | K183220 | 000 |
| B225100000150 | K183220 | 000 |