The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Integris H/hm System.
| Device ID | K925302 |
| 510k Number | K925302 |
| Device Name: | PHILIPS INTEGRIS H/HM SYSTEM |
| Classification | System, X-ray, Tomographic |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Contact | William G Mcmahon |
| Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-21 |
| Decision Date | 1992-12-17 |