Viz HCM
FDA 510(k) clearance DEN230003 · decided 2023-08-03
Clearance details
- K-number
- DEN230003
- Device name
- Viz HCM
- Applicant
- Viz. Ai, Inc.
- Decision
- Unknown
- Date received
- 2023-01-10
- Decision date
- 2023-08-03
- Days to decision
- 205 days
- Clearance type
- Direct
- Product code
- QXO
- Device class
- 2
- Regulation number
- 870.2380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EchoNext (K260332) | Pathwai, Inc. | 2026-06-08 |
Recalls involving this device
No recalls on record reference this clearance.