The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Brilliance Dual Energy Option.
| Device ID | K090462 |
| 510k Number | K090462 |
| Device Name: | BRILLIANCE DUAL ENERGY OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER ROAD Cleveland, OH 44143 |
| Contact | Michael A Chilbert |
| Correspondent | Michael A Chilbert PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER ROAD Cleveland, OH 44143 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-23 |
| Decision Date | 2009-06-23 |
| Summary: | summary |