neuropacs AIDP

Primary DI
00860016548107
Brand
neuropacs AIDP
Company
NEUROPACS CORP
Model
1.2
Device description
The neuropacs AIDP system is intended to aid neuroradiologists and/or neurologists in differentiating MSAp/PSP compared to PD, based on the analysis of degenerative brain signals on diffusion MRI using machine learning.
Published
2026-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
SHOParkinsonian Syndrome Diagnostic Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SHOParkinsonian Syndrome Diagnostic AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240071000neuropacsAutomated Imaging Diagnostics, LLC2026-04-03SHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860016548107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016548107008600165481078600165481070860016548107

GMDN Terms#

Term, Definition table
TermDefinition
Brain CT/MRI clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire computed tomography (CT) and/or magnetic resonance imaging (MRI) data of the brain (includes intracranial vessels), to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of a brain condition (e.g., occlusion, aneurysm, haemorrhage, stroke, neurodegenerative disease). It is not dedicated to treatment planning or surgical navigation, and does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
3523167323info@neuropacs.com

Regulatory Flags#

DUNS number
119569884
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false