Radify Triage
FDA 510(k) clearance K231871 · decided 2024-01-17
Clearance details
- K-number
- K231871
- Device name
- Radify Triage
- Applicant
- Envisionit Deepai, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-26
- Decision date
- 2024-01-17
- Days to decision
- 205 days
- Clearance type
- Abbreviated
- Product code
- QFM
- Device class
- 2
- Regulation number
- 892.2080
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cobham, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.