The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Mam-ch22s Mammography System With Optional Mammoguide Steriotactic Biopsy System.
| Device ID | K941353 |
| 510k Number | K941353 |
| Device Name: | MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Rochelle M Sobel |
| Correspondent | Rochelle M Sobel 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 | 1994-03-21 |
| Decision Date | 1995-03-31 |