The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Olymp-x,x-ray Generator.
| Device ID | K925684 |
| 510k Number | K925684 |
| Device Name: | OLYMP-X,X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| 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 | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1993-02-02 |