The following data is part of a premarket notification filed by Lorad, A Hologic Co. with the FDA for Modified M-iv Mammography System.
| Device ID | K011987 |
| 510k Number | K011987 |
| Device Name: | MODIFIED M-IV MAMMOGRAPHY SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | LORAD, A HOLOGIC CO. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Contact | Roaida Rizkallah |
| Correspondent | Roaida Rizkallah LORAD, A HOLOGIC CO. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-26 |
| Decision Date | 2001-07-11 |
| Summary: | summary |