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510(k) K223443

Viz AAA by Viz. Ai, Inc. — Product Code QFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2023
Date Received
November 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiological Computer-Assisted Prioritization Software For Lesions
Device Class
Class II
Regulation Number
892.2080
Review Panel
RA
Submission Type

Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification.

Other clearances by Viz. Ai, Inc.

  • K250354 — Viz Subdural+, Viz SUBDURAL PLUS (June 10, 2025)
  • K232363 — Viz HDS, Viz Volume Plus, Viz ICH+ (February 5, 2024)
  • DEN230003 — Viz HCM (August 3, 2023)
  • K223042 — Viz LVO ContaCT (October 21, 2022)
  • K221100 — Viz RV/LV (August 29, 2022)
  • K220439 — Viz SDH (July 25, 2022)
  • K213319 — Viz ANEURYSM, Viz ANX (February 18, 2022)
  • K210209 — Viz ICH (March 23, 2021)
  • K193658 — Viz ICH (March 18, 2020)
  • K180161 — Viz CTP (April 20, 2018)

Other clearances for product code QFM

  • K252482 — CogNet AI-MT+ (December 11, 2025)
  • K250831 — Annalise Enterprise (April 23, 2025)
  • K243808 — Rayvolve PTX-PE (March 21, 2025)
  • K243548 — BriefCase-Triage (December 11, 2024)
  • K241439 — VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (November 15, 2024)
  • K240612 — CINA-VCF (May 31, 2024)
  • K233108 — VinDr-Mammo (May 23, 2024)
  • K232410 — SmartChest (May 10, 2024)
  • K231871 — Radify Triage (January 17, 2024)
  • K223754 — BraveCX (November 9, 2023)