The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Brilliance Ct, Private Practice Cv Configuration, Ct Scanner.
| Device ID | K042293 |
| 510k Number | K042293 |
| Device Name: | BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Robert L Turocy |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-24 |
| Decision Date | 2004-09-08 |
| Summary: | summary |