The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Mammodiagnost Vu.
| Device ID | K083740 |
| 510k Number | K083740 |
| Device Name: | MAMMODIAGNOST VU |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 22100 BOTHELL EVERETT HIGHWAY Y Bothell, WA 98041 -8431 |
| Contact | Lynn Harmer |
| Correspondent | Melissa Deguia UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-16 |
| Decision Date | 2009-02-13 |
| Summary: | summary |