BrainSpec Core™ Software

GUDID 00860013965204

BrainSpec Core™ Software is a web-based software platform that allows for the interpretation of magnetic spectroscopy data to display relative levels of brain metabolites.

BrainSpec Inc.

Radiological PACS software
Primary Device ID00860013965204
NIH Device Record Keye13017d6-e664-477a-b56b-9ea2ad212eb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrainSpec Core™ Software
Version Model NumberBrainSpec Core™ Software
Company DUNS080177248
Company NameBrainSpec Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860013965204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-09
Device Publish Date2025-05-01

On-Brand Devices [BrainSpec Core™ Software]

00198715251623BrainSpec Core™ Software is a web-based software platform that allows for the interpretation o
00860013965204BrainSpec Core™ Software is a web-based software platform that allows for the interpretation o

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