The following data is part of a premarket notification filed by Mci Optonix, Inc. with the FDA for Mci Optonix Cassette Okamoto Cassete.
| Device ID | K945039 |
| 510k Number | K945039 |
| Device Name: | MCI OPTONIX CASSETTE OKAMOTO CASSETE |
| Classification | Cassette, Radiographic Film |
| Applicant | MCI OPTONIX, INC. P.O. BOX I 170 EAST HANOVER AVENUE Cedar Knolls, NJ 07927 |
| Contact | Joel Frey |
| Correspondent | Joel Frey MCI OPTONIX, INC. P.O. BOX I 170 EAST HANOVER AVENUE Cedar Knolls, NJ 07927 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1994-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889978964390 | K945039 | 000 |
| 60889971033734 | K945039 | 000 |
| 60889971033741 | K945039 | 000 |
| 60889971282682 | K945039 | 000 |
| 60889971395504 | K945039 | 000 |
| 60889971627582 | K945039 | 000 |
| 60889971696830 | K945039 | 000 |
| 60889971880758 | K945039 | 000 |
| 60889978002689 | K945039 | 000 |
| 60889978041978 | K945039 | 000 |
| 60889978216369 | K945039 | 000 |
| 60889978284528 | K945039 | 000 |
| 60889978427772 | K945039 | 000 |
| 60889978472239 | K945039 | 000 |
| 60889978719662 | K945039 | 000 |
| 60889971033727 | K945039 | 000 |