The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Orthopantomograph Op100d.
| Device ID | K992385 |
| 510k Number | K992385 |
| Device Name: | ORTHOPANTOMOGRAPH OP100D |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
| Contact | Tommi Jokiniemi |
| Correspondent | Tommi Jokiniemi INSTRUMENTARIUM CORP. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-16 |
| Decision Date | 1999-09-28 |