The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Nexstar Liftoff Pet Application Software Suite.
| Device ID | K081426 |
| 510k Number | K081426 |
| Device Name: | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE |
| Classification | System, Tomography, Computed, Emission |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Melinda Novatny |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-05-21 |
| Decision Date | 2008-06-04 |
| Summary: | summary |