The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Image-x 70 Intraoral X-ray System.
| Device ID | K930761 |
| 510k Number | K930761 |
| Device Name: | IMAGE-X 70 INTRAORAL X-RAY SYSTEM |
| Classification | Unit, X-ray, Intraoral |
| Applicant | AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
| Contact | Randal L Hale |
| Correspondent | Randal L Hale AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-12 |
| Decision Date | 1993-05-25 |