The following data is part of a premarket notification filed by Lorad Corp. with the FDA for Lorad 1-650 (international 650).
| Device ID | K992280 |
| 510k Number | K992280 |
| Device Name: | LORAD 1-650 (INTERNATIONAL 650) |
| Classification | System, X-ray, Mammographic |
| Applicant | LORAD CORP. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Contact | Kelvin Burroughs |
| Correspondent | Kelvin Burroughs 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 | 1999-07-07 |
| Decision Date | 1999-09-03 |
| Summary: | summary |