Viz HDS, Viz Volume Plus, Viz ICH+
FDA 510(k) K232363 · Viz. Ai, Inc.
510(k) numberK232363
Submission
- Device name
- Viz HDS, Viz Volume Plus, Viz ICH+
- Applicant
- Viz. Ai, Inc.
San Francisco, CA, US - Received
- August 7, 2023
- Decision date
- February 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Other 510(k)s with product code QIH
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|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
More from Lucida Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K250354 | Viz Subdural+, Viz SUBDURAL PLUSQIH · Traditional | 06/10/2025SE |
| K223443 | Viz AAAQFM · Traditional | 03/17/2023SE |
| K223042 | Viz LVO ContaCTQAS · Special | 10/21/2022SE |
| K221100 | Viz RV/LVQIH · Traditional | 08/29/2022SE |
| K220439 | Viz SDHQAS · Traditional | 07/25/2022SE |
| K213319 | Viz ANEURYSM, Viz ANXQFM · Traditional | 02/18/2022SE |
| K210209 | Viz ICHQAS · Traditional | 03/23/2021SE |
| K193658 | Viz ICHQAS · Traditional | 03/18/2020SE |
| K180161 | Viz CTPLLZ · Traditional | 04/20/2018SE |
Questions and answers
When was Viz HDS, Viz Volume Plus, Viz ICH+ cleared by the FDA?
Viz HDS, Viz Volume Plus, Viz ICH+ (K232363) received a 510(k) decision of Substantially Equivalent on February 5, 2024, 182 days after the submission was received.
What is the product code of K232363?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.