The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Brightview Vct Imaging System.
| Device ID | K080927 |
| 510k Number | K080927 |
| Device Name: | BRIGHTVIEW VCT IMAGING SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 540 ALDER DRIVE Milpitas, CA 95035 |
| Contact | Coleen A Coleman |
| Correspondent | Morten Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-02 |
| Decision Date | 2008-04-11 |
| Summary: | summary |