The following data is part of a premarket notification filed by Lorad, A Hologic Co. with the FDA for Digital Stereoloc Ii.
| Device ID | K071542 |
| 510k Number | K071542 |
| Device Name: | DIGITAL STEREOLOC II |
| Classification | System, X-ray, Mammographic |
| Applicant | LORAD, A HOLOGIC CO. 36 APPLE RIDGE RD. Danbury, CT 06810 |
| Contact | Gail Yaeker-daunis |
| Correspondent | Gail Yaeker-daunis 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 | 2007-06-05 |
| Decision Date | 2007-07-05 |
| Summary: | summary |