Spectral Bone Marrow 5929650

GUDID 00195278630377

Spectral Bone Marrow MD Application Container for Smart Subscription

GE MEDICAL SYSTEMS, INC.

CT system application software

• Primary Device ID: 00195278630377
• NIH Device Record Key: 6881507b-9eea-4b0e-9685-6586b7f763f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectral Bone Marrow
• Version Model Number: 1.0
• Catalog Number: 5929650
• 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	00195278630377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223514

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25

Devices Manufactured by GE MEDICAL SYSTEMS, INC.

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• 00195278901439 - Omni: 2024-09-23 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY - WSO
• 00195278454218 - Omni: 2024-08-15 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY
• 00195278840226 - Discovery: 2024-07-12 XR656HD UDI Label
• 00195278840233 - Optima: 2024-07-12 XR646HD UDI Label
• 00195278792822 - Omni: 2024-04-19 OMNI GANTRY ELECTRONICS ASSY, MEA