The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Orthoralix Sd/orthoralix Sd Ceph.
| Device ID | K890351 |
| 510k Number | K890351 |
| Device Name: | ORTHORALIX SD/ORTHORALIX SD CEPH |
| Classification | System, X-ray, Tomographic |
| 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 | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-24 |
| Decision Date | 1989-06-15 |