510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240071Unknown

neuropacs

Automated Imaging Diagnostics, LLC, Gainesville FL / Direct, Unknown
FDA source (opens on fda.gov)

DEN240071 is the FDA 510(k) clearance record for neuropacs, a class II device, cleared for Automated Imaging Diagnostics, LLC on under FDA product code SHO (Parkinsonian Syndrome Diagnostic Aid). FDA's definition for product code SHO reads: "A Parkinsonian syndrome diagnostic aid is a prescription device that analyzes patient-specific data to aid in the diagnosis of Parkinsonian syndromes. This device is intended for adjunctive use and not intended as a stand-alone diagnostic". FDA records list one 510(k) clearance for Automated Imaging Diagnostics, LLC. As of , FDA records show no recalls naming DEN240071.

Clearance record

Decision date
Received
(485 days to decision)
Product code
SHO Parkinsonian Syndrome Diagnostic Aid
Regulation
21 CFR 882.2000
Device class
Class II
Review panel
Neurology
Applicant
Automated Imaging Diagnostics, LLC 9706 SW 34th Ln., Gainesville FL
Third party review
No

Clearances, product code SHO

Trailing 12 months
1 clearance under product code SHO in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260