FDA product code OEO: Automated Digital Image Manual Interpretation Microscope
OEO is the FDA product code for automated digital image manual interpretation microscope. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. FDA has cleared 6 510(k) submissions under OEO, from 5 different applicants. The average 510(k) review took 293 days (median 274).
Definition
The ihc her2 manual read of a digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of her2/neu (c-erbb-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for her-2 receptors, using microscopy images displayed on a computer monitor. Her-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes in breast cancer.
Classification
| Field | Value |
|---|---|
| Device name | Automated Digital Image Manual Interpretation Microscope |
| Device class | Class II |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OEO clearance
Top OEO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aperio Technologies | 2 | 2008-10-31 |
| Ventana Medical Systems, Inc. | 1 | 2015-07-16 |
| Omnyx, LLC | 1 | 2014-04-01 |
| Philips Medical Systems Nederland B.V. | 1 | 2013-09-19 |
| Olympus America Inc. / Scientific Equipment Group | 1 | 2012-08-21 |
Most recent OEO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142965 | Ventana Medical Systems, Inc. | Virtuoso System for IHC PR (1E2) using iScan HT | 2015-07-16 | 275 |
| K131140 | Omnyx, LLC | OMNYX IDP FOR HER2 MANUAL APPLICATION | 2014-04-01 | 344 |
| K130021 | Philips Medical Systems Nederland B.V. | PHILIPS HERCEPTEST DIGITAL SCORE | 2013-09-19 | 259 |
| K111914 | Olympus America Inc. / Scientific Equipment Group | VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM | 2012-08-21 | 412 |
| K080254 | Aperio Technologies | SCANSCOPE XT SYSTEM | 2008-10-31 | 274 |
Recalls for OEO devices
openFDA lists no recalls for product code OEO.
Frequently asked questions
What is FDA product code OEO?
OEO is the FDA product code for automated digital image manual interpretation microscope. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is OEO?
Class II, regulation 21 CFR 864.1860. Typical premarket route: 510(k).
How long does a 510(k) take for product code OEO?
Across 6 cleared submissions the average was 293 days from receipt to decision (median 274).
Which companies have the most OEO clearances?
Aperio Technologies (2); Ventana Medical Systems, Inc. (1); Omnyx, LLC (1); Philips Medical Systems Nederland B.V. (1); Olympus America Inc. / Scientific Equipment Group (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OEO
- Run a recall and safety report across every OEO manufacturer
- Watch product code OEO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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