The following data is part of a premarket notification filed by Lorad Corp. with the FDA for Digital Spot Mammography For Sterotactic Application.
| Device ID | K950608 |
| 510k Number | K950608 |
| Device Name: | DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION |
| Classification | System, X-ray, Mammographic |
| Applicant | LORAD CORP. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Contact | Marvin Rosenbaum |
| Correspondent | Marvin Rosenbaum 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 | 1995-02-09 |
| Decision Date | 1995-03-02 |