SnapShot Freeze

GUDID 00840682142601

GE MEDICAL SYSTEMS, INC.

CT system application software

• Primary Device ID: 00840682142601
• NIH Device Record Key: 90b0fc4e-ee8e-4f4c-bb00-3a68ad62f68f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SnapShot Freeze
• Version Model Number: 2
• 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: false
• Serial Number: true
• 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	00840682142601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120910

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: 2
• Public Version Date: 2019-07-09
• Device Publish Date: 2018-09-05

Devices Manufactured by GE MEDICAL SYSTEMS, INC.

• 00195278560384 - Auto Segmentation: 2024-11-13 MD Auto Segmentation for Smart Subscription
• 00195278865335 - SnapShot Freeze 2: 2024-10-21 SnapShot Freeze Medical Device
• 00195278804990 - Revolution: 2024-09-23 Revolution UPG3 - Designated System Medical Device
• 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