Neosoma Glioma

GUDID 00860009223653

Neosoma, Inc.

Image segmentation application software
Primary Device ID00860009223653
NIH Device Record Key61b5080e-bbf8-49ad-9a53-b5ac300f4d1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeosoma Glioma
Version Model Number2
Company DUNS118206040
Company NameNeosoma, 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009223639 [Previous]
GS100860009223653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

Devices Manufactured by Neosoma, Inc.

00860009223653 - Neosoma Glioma2025-03-28
00860009223653 - Neosoma Glioma2025-03-28
00860009223646 - Neosoma Dashboard2023-11-22
00860009223608 - Neosoma HGG2023-11-07
00860009223615 - Neosoma Dashboard2023-11-07
00860009223622 - Neosoma Dashboard2023-09-14
00860009223639 - Neosoma HGG2023-09-14

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