The following data is part of a premarket notification filed by Olympus with the FDA for Olympus Imagemanager System.
| Device ID | K934889 |
| 510k Number | K934889 |
| Device Name: | OLYMPUS IMAGEMANAGER SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | OLYMPUS 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-13 |
| Decision Date | 1994-01-28 |