The following data is part of a premarket notification filed by Bennett X-ray Technologies with the FDA for Bennett X-ray Digital Spot Imager.
| Device ID | K935428 |
| 510k Number | K935428 |
| Device Name: | BENNETT X-RAY DIGITAL SPOT IMAGER |
| Classification | System, X-ray, Mammographic |
| Applicant | BENNETT X-RAY TECHNOLOGIES 445 OAK ST. Copiague, NY 11726 -2798 |
| Contact | Robert P Coe |
| Correspondent | Robert P Coe BENNETT X-RAY TECHNOLOGIES 445 OAK ST. Copiague, NY 11726 -2798 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-10 |
| Decision Date | 1994-11-01 |