The following data is part of a premarket notification filed by Orthoscan, Inc. with the FDA for Orthoscan, Orthoscan Hd.
| Device ID | K051754 |
| 510k Number | K051754 |
| Device Name: | ORTHOSCAN, ORTHOSCAN HD |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | ORTHOSCAN, INC. 8585 E HARTFORD DRIVE Scottsdale, AZ 85255 |
| Contact | Arlen Issette |
| Correspondent | Arlen Issette ORTHOSCAN, INC. 8585 E HARTFORD DRIVE Scottsdale, AZ 85255 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-29 |
| Decision Date | 2005-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B225100000040 | K051754 | 000 |