The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Imagemanager System Version 6.0 For Windows.
| Device ID | K952888 |
| 510k Number | K952888 |
| Device Name: | OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-23 |
| Decision Date | 1995-09-18 |