neuropacs
FDA 510(k) clearance DEN240071 · decided 2026-04-03
Clearance details
- K-number
- DEN240071
- Device name
- neuropacs
- Applicant
- Automated Imaging Diagnostics, LLC
- Decision
- Unknown
- Date received
- 2024-12-04
- Decision date
- 2026-04-03
- Days to decision
- 485 days
- Clearance type
- Direct
- Product code
- SHO
- Device class
- 2
- Regulation number
- 882.2000
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.