The following data is part of a premarket notification filed by Vucomp, Inc. with the FDA for M-vu Breast Density.
| Device ID | K132742 |
| 510k Number | K132742 |
| Device Name: | M-VU BREAST DENSITY |
| Classification | System, Image Processing, Radiological |
| Applicant | VUCOMP, INC. 2500 NORTH DALLAS PARKWAY SUITE 500 Plano, TX 75093 |
| Contact | Richard Morroney |
| Correspondent | Richard Morroney VUCOMP, INC. 2500 NORTH DALLAS PARKWAY SUITE 500 Plano, TX 75093 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2013-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005656 | K132742 | 000 |
| 00858012005205 | K132742 | 000 |