Spectral Color Overlay 5973668

GUDID 00195278932341

Spectral Color Overlay Medical Device

GE MEDICAL SYSTEMS, INC.

CT system application software

• Primary Device ID: 00195278932341
• NIH Device Record Key: 151b04b9-cd21-487c-b766-5cbe6a389e4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectral Color Overlay
• Version Model Number: 1.1
• Catalog Number: 5973668
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278932341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121827

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-03
• Device Publish Date: 2026-01-26

On-Brand Devices [Spectral Color Overlay]

• 00195278630384: Spectral Color Overlay MD Application Container for Smart Subscription
• 00195278932341: Spectral Color Overlay Medical Device