The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Philips Comprehensive Cardiac Analysis (cca) - Plaque Assessment Tool.
| Device ID | K092747 |
| 510k Number | K092747 |
| Device Name: | PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Michael A Chilbert |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-08 |
| Decision Date | 2009-10-09 |
| Summary: | summary |