Viz AAA
FDA 510(k) clearance K223443 · decided 2023-03-17
Clearance details
- K-number
- K223443
- Device name
- Viz AAA
- Applicant
- Viz. Ai, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-14
- Decision date
- 2023-03-17
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- QFM
- Device class
- 2
- Regulation number
- 892.2080
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.