The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Xrg 90 X-ray Generator System.
| Device ID | K933650 |
| 510k Number | K933650 |
| Device Name: | PHILIPS XRG 90 X-RAY GENERATOR SYSTEM |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Contact | William G Mcmahon |
| Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1993-10-07 |