The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Xenon Option To Prism 3000.
| Device ID | K955484 |
| 510k Number | K955484 |
| Device Name: | XENON OPTION TO PRISM 3000 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Norman J Yager |
| Correspondent | Norman J Yager PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-01 |
| Decision Date | 1996-03-29 |
| Summary: | summary |