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Sign in to claim this brandOmnyx, LLC
United States·US-MF-000025160
Last updated September 18, 2026
About
Cancer data management and AI-powered casefinding and abstracting. See how Inspirata helps cancer registries do more with less.
From the manufacturer's own website. Source
What Omnyx, LLC makes
Omnyx, LLC develops software applications for pathology information systems, including tools for digital pathology and manual application of diagnostic markers. Their products focus on managing cancer-related data and facilitating casefinding and abstracting processes within pathology workflows.
The company’s software portfolio is classified as Class II medical devices and is authorised through FDA pathways, including 510(k) clearances and the Unique Device Identifier (UDI) system. The products are listed under regulatory registries in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Omnyx, LLC manufacture?
Omnyx, LLC specializes in developing software applications for pathology information systems. Their primary focus is on digital pathology tools and manual application software for diagnostic markers, such as their products for managing cancer-related data, including casefinding and abstracting. These tools are designed to streamline workflows in pathology settings.
Where is Omnyx, LLC based, and what regulatory pathways do its devices follow?
Omnyx, LLC is based in the United States. Their devices are authorised through FDA pathways, including 510(k) clearances and the Unique Device Identifier (UDI) system. These pathways ensure compliance with U.S. regulatory requirements for medical devices.
Which regulatory registries list Omnyx, LLC’s devices?
Omnyx, LLC’s devices are listed in U.S. regulatory registries, specifically under the FDA’s 510(k) clearance and UDI systems. These registries track authorised medical devices to ensure transparency and compliance with U.S. regulations.
How are Omnyx, LLC’s devices classified under medical device regulations?
Omnyx, LLC’s software applications for pathology information systems fall under Class II medical device classification. This classification is determined by the FDA based on the risk associated with the device’s intended use, and it requires compliance with specific regulatory controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1251, Waterfront Place, Pittsburgh, United States
- Website
- www.inspirata.com
- linkedin.com/company/inspirata-inc
- facebook.com/InspirataCancerCare
- [email protected]
- Phone
- +1 813 570 8976
- PRRC Contact
- Richard Morroney, RAC, CQA
- EUDAMED SRN
- US-MF-000025160
- FDA FEI Number
- —
- DUNS Number
- 002116917
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dynamyx Digital Pathology Software | 2.4 | FDA UDI | Class II | Active |
| Omnyx Idp For Her2 Manual Application | K131140 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Omnyx, LLC has one recall record initiated on 2013-10-01, which is marked as terminated. The recall pertains to the Digital Pathology System (DPS) Software version 1.1 Image Viewer, where the annotation tools may display incorrect measurements and area calculations for regions of interest on scanned slides under specific conditions.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 1, 2013 | Z-0469-2014 | — | terminated | There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions. |