FDA applicant
Viz. Ai, Inc.
FDA records 11 decisions for Viz. Ai, Inc. (San Francisco, CA) from 2018 to 2025: 10 510(k) clearances and 1 De Novo grant. Most are in product codes QAS (Radiological Computer-Assisted Triage And…) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Viz. Ai, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Viz. Ai, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report