The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Lorad Digital Spot Mammography System.
| Device ID | K040884 |
| 510k Number | K040884 |
| Device Name: | LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury, CT 06810 |
| Contact | Gail Yaeker-daunis |
| Correspondent | Gail Yaeker-daunis HOLOGIC, INC. 36 APPLE RIDGE ROAD 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 | 2004-04-05 |
| Decision Date | 2004-04-23 |
| Summary: | summary |