The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Pq-2000+ Computed Tomography X-ray System.
| Device ID | K955268 |
| 510k Number | K955268 |
| Device Name: | PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Robert L Turocy |
| Correspondent | Robert L Turocy PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. 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 | 1995-11-17 |
| Decision Date | 1996-01-30 |