VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
FDA 510(k) clearance K111914 · decided 2012-08-21
Clearance details
- K-number
- K111914
- Device name
- VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
- Applicant
- Olympus America Inc. / Scientific Equipment Group
- Decision
- Substantially Equivalent
- Date received
- 2011-07-06
- Decision date
- 2012-08-21
- Days to decision
- 412 days
- Clearance type
- Traditional
- Product code
- OEO
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
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| PHILIPS HERCEPTEST DIGITAL SCORE (K130021) | Philips Medical Systems Nederland B.V. | 2013-09-19 |
| SCANSCOPE XT SYSTEM (K080254) | Aperio Technologies | 2008-10-31 |
| SCANSCOPE XT SYSTEM (K071671) | Aperio Technologies | 2007-12-28 |
Recalls involving this device
No recalls on record reference this clearance.