DEVICE: BrainSpec Core™ Software (00860013965204)

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Device Identifier (DI) Information
BrainSpec Core™ Software
BrainSpec Core™ Software
In Commercial Distribution

BrainSpec Inc.
00860013965204
GS1

1
080177248 *Terms of Use
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.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
41670 Radiological PACS software
An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.
Active false
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FDA Product Code

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Product Code Product Code Name
LLZ System, Image Processing, Radiological
LNI System, Nuclear Magnetic Resonance Spectroscopic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K230856 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
e13017d6-e664-477a-b56b-9ea2ad212eb7
May 09, 2025
1
May 01, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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