Viz AAA
FDA 510(k) K223443 · Viz. Ai, Inc.
510(k) numberK223443
Submission
- Device name
- Viz AAA
- Applicant
- Viz. Ai, Inc.
San Francisco, CA, US - Received
- November 14, 2022
- Decision date
- March 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFM – Radiological Computer-Assisted Prioritization Software For Lesions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
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…
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| K210209 | Viz ICHQAS · Traditional | 03/23/2021SE |
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Questions and answers
When was Viz AAA cleared by the FDA?
Viz AAA (K223443) received a 510(k) decision of Substantially Equivalent on March 17, 2023, 123 days after the submission was received.
What is the product code of K223443?
The FDA product code is QFM – Radiological Computer-Assisted Prioritization Software For Lesions, a Class II (moderate risk) device regulated under 21 CFR 892.2080.