Neosoma HGG

GUDID 00860009223608

Neosoma, Inc.

Image segmentation application software

• Primary Device ID: 00860009223608
• NIH Device Record Key: 31982147-beff-4e1b-8958-af131fa4f944
• Commercial Distribution Discontinuation: 2023-09-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Neosoma HGG
• Version Model Number: 2.1.2.0
• Company DUNS: 118206040
• Company Name: Neosoma, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009223608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221738

FDA Product Code

• QIH: Automated Radiological Image Processing Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-07
• Device Publish Date: 2022-12-22

On-Brand Devices [Neosoma HGG]

• 00860009223639: 2
• 00860009223608: 2.1.2.0