Virtuoso System for IHC PR (1E2) using iScan HT
FDA 510(k) K142965 · Ventana Medical Systems, Inc.
Submission
- Device name
- Virtuoso System for IHC PR (1E2) using iScan HT
- Applicant
- Ventana Medical Systems, Inc.
Mountain View, CA, US - Received
- October 14, 2014
- Decision date
- July 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OEO – Automated Digital Image Manual Interpretation Microscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Specialty
- Hematology
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…
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Questions and answers
When was Virtuoso System for IHC PR (1E2) using iScan HT cleared by the FDA?
Virtuoso System for IHC PR (1E2) using iScan HT (K142965) received a 510(k) decision of Substantially Equivalent on July 16, 2015, 275 days after the submission was received.
What is the product code of K142965?
The FDA product code is OEO – Automated Digital Image Manual Interpretation Microscope, a Class II (moderate risk) device regulated under 21 CFR 864.1860.