510(k) K131140
- Device
- OMNYX IDP FOR HER2 MANUAL APPLICATION
- Applicant
- OMNYX, LLC
- 510(k) number
- K131140
- Product code
- OEO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-01
- Date received
- 2013-04-22
- Regulation
- 864.1860
- Classification name
- Automated Digital Image Manual Interpretation Microscope
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GAIL E RADCLIFFE
- Address
- 62 Forest St., Suite 300 Marlborough MA US 01752 01752
FDA Registration Numbers#
- 2028492
- 3003537036
Source Documents#
Other 510(k) Records For Product Code OEO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | Ventana Medical Systems, Inc. | 2015-07-16 |
| K130021 | PHILIPS HERCEPTEST DIGITAL SCORE | Philips Medical Systems Nederland B.V. | 2013-09-19 |
| K111914 | VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM | Olympus America Inc. / Scientific Equipment Group | 2012-08-21 |
| K080254 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2008-10-31 |
| K071671 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2007-12-28 |
Legacy Summary#
summary
FDA Review#
Decision Summary