Omnyx Idp for HER2 Manual Application
FDA 510(k) K131140 · Omnyx, LLC
510(k) numberK131140
Submission
- Device name
- Omnyx Idp for HER2 Manual Application
- Applicant
- Omnyx, LLC
Marlborough, MA, US - Received
- April 22, 2013
- Decision date
- April 1, 2014
- 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…
Other 510(k)s with product code OEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HTOEO · Traditional | Ventana Medical Systems, Inc. | 07/16/2015SE |
| K130021 | Philips Herceptest Digital ScoreOEO · Traditional | Philips Medical Systems Nederland B.V. | 09/19/2013SE |
| K111914 | Virtual Slide System, Olympus VS800 SystemOEO · Traditional | Olympus America Inc. / Scientific Equipment Group | 08/21/2012SE |
| K080254 | Scanscope XT SystemOEO · Traditional | Aperio Technologies | 10/31/2008SE |
| K071671 | Scanscope XT SystemOEO · Traditional | Aperio Technologies | 12/28/2007SE |
Questions and answers
When was Omnyx Idp for HER2 Manual Application cleared by the FDA?
Omnyx Idp for HER2 Manual Application (K131140) received a 510(k) decision of Substantially Equivalent on April 1, 2014, 344 days after the submission was received.
What is the product code of K131140?
The FDA product code is OEO – Automated Digital Image Manual Interpretation Microscope, a Class II (moderate risk) device regulated under 21 CFR 864.1860.