The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for R2 Digitalnow Hd(digitalnow Hd).
| Device ID | K091368 |
| 510k Number | K091368 |
| Device Name: | R2 DIGITALNOW HD(DIGITALNOW HD) |
| Classification | System, Image Processing, Radiological |
| Applicant | HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730 |
| Contact | Michaela Mahl |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2009-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045504806 | K091368 | 000 |