The following data is part of a premarket notification filed by Lorad Corp. with the FDA for Lorad M-iii Elite (m-iii E).
| Device ID | K973631 |
| 510k Number | K973631 |
| Device Name: | LORAD M-III ELITE (M-III E) |
| Classification | System, X-ray, Mammographic |
| Applicant | LORAD CORP. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Contact | Philip G Juhas |
| Correspondent | Philip G Juhas LORAD CORP. 36 APPLE RIDGE RD. 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 | 1997-09-24 |
| Decision Date | 1997-12-23 |
| Summary: | summary |