The following data is part of a premarket notification filed by Instrumentarium Imaging, Inc. with the FDA for Orthopantomograph Op100 And Orthoceph Oc100.
| Device ID | K973642 |
| 510k Number | K973642 |
| Device Name: | ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-24 |
| Decision Date | 1997-11-21 |