The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Dr Imagepro.
| Device ID | K032546 |
| 510k Number | K032546 |
| Device Name: | HOLOGIC DR IMAGEPRO |
| Classification | System, Image Processing, Radiological |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Daniel F Phelan |
| Correspondent | Daniel F Phelan HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-18 |
| Decision Date | 2003-10-16 |
| Summary: | summary |