The following data is part of a premarket notification filed by Lorad Corp. with the FDA for Lorad M-iii.
| Device ID | K934625 |
| 510k Number | K934625 |
| Device Name: | LORAD M-III |
| Classification | System, X-ray, Mammographic |
| Applicant | LORAD CORP. 28 EAGLE ROAD, COMMERCE PARK Danbury, CT 06810 |
| Contact | Barry B Wrenn |
| Correspondent | Barry B Wrenn LORAD CORP. 28 EAGLE ROAD, COMMERCE PARK Danbury, CT 06810 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-27 |
| Decision Date | 1994-01-28 |