DEVICE: BrainSpec Core™ Software (00198715251623)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
BrainSpec Core™ Software
BrainSpec Core™ Software
Not in Commercial Distribution

BrainSpec Inc.
00198715251623
GS1
May 01, 2025
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.
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LLZ System, Image Processing, Radiological
LNI System, Nuclear Magnetic Resonance Spectroscopic
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K230856 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
0fd9b7aa-04df-4c86-b04e-306918901290
May 02, 2025
2
February 10, 2025
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE