The following data is part of a premarket notification filed by Olympus America Inc. / Scientific Equipment Group with the FDA for Virtual Slide System, Olympus Vs800 System.
| Device ID | K111914 |
| 510k Number | K111914 |
| Device Name: | VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM |
| Classification | Automated Digital Image Manual Interpretation Microscope |
| Applicant | OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | OEO |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-06 |
| Decision Date | 2012-08-21 |
| Summary: | summary |