The following data is part of a premarket notification filed by Oy Ajat, Ltd. with the FDA for Scan300fp / Retropan (vdc).
| Device ID | K051664 |
| 510k Number | K051664 |
| Device Name: | SCAN300FP / RETROPAN (VDC) |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | OY AJAT, LTD. 110 E GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Claude D Berthoin |
| Correspondent | Claude D Berthoin OY AJAT, LTD. 110 E GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-22 |
| Decision Date | 2005-07-20 |