Viz HDS, Viz Volume Plus, Viz ICH+
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Viz.ai, Inc.
Identifiers
- 510(k) Number
- K232363 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Viz HDS, Viz Volume Plus, and Viz ICH+ are automated imaging analysis systems designed for quantitative assessment of medical images. These devices utilize advanced algorithms to measure and analyze anatomical structures, such as intracranial hemorrhage (ICH) volumes, hydrocephalus, and other volumetric data from computed tomography (CT) scans, aiding in clinical decision-making and diagnostic accuracy.
These systems are intended for use in radiology departments and clinical settings where CT imaging is performed. Supplied as software applications, they are intended for single-use per imaging study, though the underlying software may be installed on a reusable workstation. The devices are not classified as MRI-safe or MRI-conditional, and no specific sterility requirements are noted. Authorization for these devices includes FDA 510K clearance under the product code QIH, with a decision classification of Substantially Equivalent, as reviewed by the Radiology Advisory Committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232363 | Class II | Active |
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Manufacturer
- Manufacturer
- Viz.ai, Inc.
- FDA Applicant
- Viz. Ai, Inc.
Sources (2)
- FDA 510(k) K232363 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026