The following data is part of a premarket notification filed by Orion Corporation Soredex with the FDA for Cranex Tome Ceph, Or Cranex Tome.
| Device ID | K974877 |
| 510k Number | K974877 |
| Device Name: | CRANEX TOME CEPH, OR CRANEX TOME |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | ORION CORPORATION SOREDEX P.O. BOX 79 Helsinki, FI Fin-00511 |
| Contact | Kai Laner |
| Correspondent | Kai Laner ORION CORPORATION SOREDEX P.O. BOX 79 Helsinki, FI Fin-00511 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-03-27 |
| Summary: | summary |