# Viz. Ai, Inc.

- Location (FDA's records): San Francisco, CA
- FDA decisions: 11 (2018–2025): 10 510(k) clearances and 1 De Novo grant
- Product codes: QAS (4), QIH (3), QFM (2), LLZ (1), QXO (1)
- 510(k) review time since 2016: median 123 days, against 119 for FDA's reviews in the same codes and years (6 of 10 faster)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 22 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Viz.Al, Inc.: 2 (https://510kreport.com/company/viz-al)
- Shanghai United Imaging Intelligence Co., Ltd.: 1 (https://510kreport.com/company/shanghai-united-imaging-intelligence)
- Imbio, LLC: 1 (https://510kreport.com/company/imbio)
- Aidoc Medical, Ltd.: 1 (https://510kreport.com/company/aidoc-medical)
- Ischemaview, Inc.: 1 (https://510kreport.com/company/ischemaview)
- Qure.Ai Technologies: 1 (https://510kreport.com/company/qure-ai-technologies)

## Firms that cite its devices most
- Brainomix Limited: 3 (https://510kreport.com/company/brainomix)
- JLK, Inc.: 3 (https://510kreport.com/company/jlk)
- Corvista Health, Inc.: 1 (https://510kreport.com/company/corvista-health)
- Tempus AI, Inc.: 1 (https://510kreport.com/company/tempus-ai)
- Neurocareai, Inc.: 1 (https://510kreport.com/company/neurocareai)
- Ischemaview, Inc.: 1 (https://510kreport.com/company/ischemaview)
- Anumana, Inc.: 1 (https://510kreport.com/company/anumana)
- Apple, Inc.: 1 (https://510kreport.com/company/apple)

## Its most-cited devices
- DEN230003: Viz HCM (2023), cited by 5
- K193658: Viz ICH (2020), cited by 4
- K223042: Viz LVO ContaCT (2022), cited by 3
- K210209: Viz ICH (2021), cited by 2
- K213319: Viz ANEURYSM, Viz ANX (2022), cited by 2
- K180161: Viz CTP (2018), cited by 2

## Recent decisions
- K250354: Viz Subdural+, Viz SUBDURAL PLUS (Jun 10, 2025)
- K232363: Viz HDS, Viz Volume Plus, Viz ICH+ (Feb 5, 2024)
- DEN230003: Viz HCM (Aug 3, 2023)
- K223443: Viz AAA (Mar 17, 2023)
- K223042: Viz LVO ContaCT (Oct 21, 2022)
- K221100: Viz RV/LV (Aug 29, 2022)
- K220439: Viz SDH (Jul 25, 2022)
- K213319: Viz ANEURYSM, Viz ANX (Feb 18, 2022)

Source page: https://510kreport.com/company/viz-ai