Clearance Summary
VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM received FDA 510(k) clearance under submission number K111914, sponsored by Olympus America Inc. / Scientific Equipment Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2012-08-21.
- Submission: K111914
- Applicant / Sponsor: Olympus America Inc. / Scientific Equipment Group
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2012-08-21
Classification & Regulation
This clearance is catalogued under FDA product code OEO and 21 CFR 864.1860, within the Hematology review panel as a Class II device.