510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OEOClass II

Automated Digital Image Manual Interpretation Microscope

21 CFR 864.1860 / Hematology
FDA source (opens on fda.gov)

OEO is the FDA product code for Automated Digital Image Manual Interpretation Microscope, a class II device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "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...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OEO
Device name
Automated Digital Image Manual Interpretation Microscope
FDA 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.
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code OEO

By decision year
6 clearances under product code OEO with a decision year between 2007 and 2015, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OEO by decision year
YearClearances
20071
20081
20121
20131
20141
20151

Applicants with the most clearances

Product code OEO
Applicants holding the most 510(k) clearances under product code OEO
ApplicantClearances
Leica Biosystems Imaging, Inc.2
Olympus America Inc. / Scientific Equipment Group1
Omnyx, LLC1
Philips Medical Systems Nederland B.V.1
Ventana Medical Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code