510(k) K111914

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 21, 2012

Date Received

July 6, 2011

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Automated Digital Image Manual Interpretation Microscope

Device Class

Class II

Regulation Number

864.1860

Review Panel

PA

Submission Type

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.