Panels › Hematology › Product code OEO · Class 2
Automated Digital Image Manual Interpretation Microscope
Regulation 864.1860
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OEO
| Company | 510(k)s | Recalls |
|---|---|---|
| Aperio Technologies | 2 | 0 |
| Olympus America Inc. / Scientific Equipment Group | 1 | 0 |
| Omnyx, LLC | 1 | 0 |
| Philips Medical Systems Nederland B.V. | 1 | 0 |
| Ventana Medical Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 16, 2015 | K142965 | Virtuoso System for IHC PR (1E2) using iScan HT Ventana Medical Systems, Inc. | OEO |
| Apr 1, 2014 | K131140 | OMNYX IDP FOR HER2 MANUAL APPLICATION Omnyx, LLC | OEO |
| Sep 19, 2013 | K130021 | PHILIPS HERCEPTEST DIGITAL SCORE Philips Medical Systems Nederland B.V., NL | OEO |
| Aug 21, 2012 | K111914 | VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM Olympus America Inc. / Scientific Equipment Group | OEO |
| Oct 31, 2008 | K080254 | SCANSCOPE XT SYSTEM Aperio Technologies | OEO |
| Dec 28, 2007 | K071671 | SCANSCOPE XT SYSTEM Aperio Technologies | OEO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.