The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Unifi Workspace V1.0.0.
| Device ID | K190694 |
| 510k Number | K190694 |
| Device Name: | Unifi Workspace V1.0.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Hologic, Inc. 36 Apple Ridge Road Danbury, CT 06810 |
| Contact | Meghan Wakeford |
| Correspondent | Meghan Wakeford Hologic, Inc. 36 Apple Ridge Road Danbury, CT 06810 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045512634 | K190694 | 000 |
| 15420045511859 | K190694 | 000 |