The following data is part of a premarket notification filed by Bennett X-ray Corp. with the FDA for Profile Mammography System (m-pro).
| Device ID | K964576 |
| 510k Number | K964576 |
| Device Name: | PROFILE MAMMOGRAPHY SYSTEM (M-PRO) |
| Classification | System, X-ray, Mammographic |
| Applicant | BENNETT X-RAY CORP. 445 OAK ST. Copiague, NY 11726 |
| Contact | John A Shovary |
| Correspondent | John A Shovary BENNETT X-RAY CORP. 445 OAK ST. Copiague, NY 11726 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-14 |
| Decision Date | 1997-01-10 |
| Summary: | summary |