Delivery Date AI
FDA 510(k) clearance DEN250007 · decided 2026-02-11
Clearance details
- K-number
- DEN250007
- Device name
- Delivery Date AI
- Applicant
- Ultrasound AI
- Decision
- Unknown
- Date received
- 2025-03-17
- Decision date
- 2026-02-11
- Days to decision
- 331 days
- Clearance type
- Direct
- Product code
- SHE
- Device class
- 2
- Regulation number
- 892.8200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Greenwood Village, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.