The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Mam-ch22s With Automatic Filter Selection Option.
| Device ID | K960381 |
| 510k Number | K960381 |
| Device Name: | MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION |
| Classification | System, X-ray, Mammographic |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Thomas J Spackman, M.d., F.a.c.r. |
| Correspondent | Thomas J Spackman, M.d., F.a.c.r. ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-26 |
| Decision Date | 1996-04-29 |
| Summary: | summary |