MAR

GUDID 00840682134989

GE MEDICAL SYSTEMS, INC.

CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software CT system application software

• Primary Device ID: 00840682134989
• NIH Device Record Key: 6498c879-1aeb-44b0-8b30-116912ef7b52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAR
• Version Model Number: 1.0
• 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: true
• 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	00840682134989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132410

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-25

Devices Manufactured by GE MEDICAL SYSTEMS, INC.

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• 00195278584441 - Quality Care Suite: 2023-09-22 Quality Care Suite 2.0, Medical Device
• 00195278629586 - Head Auto Views: 2023-09-04 Head Auto Views MD Application Container for Smart Subscription
• 00195278630377 - Spectral Bone Marrow: 2023-09-04 Spectral Bone Marrow MD Application Container for Smart Subscription
• 00195278630384 - Spectral Color Overlay: 2023-09-04 Spectral Color Overlay MD Application Container for Smart Subscription
• 00195278518866 - Revolution: 2023-04-10 Revolution CT Power - Designated System Medical Device