The following data is part of a premarket notification filed by Philips Nuclear Medicine, Inc with the FDA for Nm Application Suite.
| Device ID | K080961 |
| 510k Number | K080961 |
| Device Name: | NM APPLICATION SUITE |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS NUCLEAR MEDICINE, INC 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Lori R Peterson |
| Correspondent | Morten Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-04 |
| Decision Date | 2008-04-18 |
| Summary: | summary |