neuropacs— 510(k) DEN240071
UnknownAutomated Imaging Diagnostics, LLC
FDA 510(k) clearance DEN240071 for neuropacs, Unknown on 2026-04-03. Applicant: Automated Imaging Diagnostics, LLC. Device class: 2.
Summary
Automated Imaging Diagnostics' neuropacs is filed under product code SHO (Parkinsonian Syndrome Diagnostic Aid). The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 882.2000. Neurology is both the classification panel and the review panel. The record lists the submission type as Direct.
Automated Imaging Diagnostics filed from Gainesville, Florida. Review took 485 calendar days (December 4, 2024 to April 3, 2026).
Clearance details
- Applicant
- Automated Imaging Diagnostics, LLC
- Product code
- Product code SHO
- Device class
- Class 2
- Regulation
- 21 CFR 882.2000
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Gainesville, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.