Discovery

GUDID 00195278098603

PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make

GE MEDICAL SYSTEMS, INC.

Full-body CT system

• Primary Device ID: 00195278098603
• NIH Device Record Key: 89250495-f71c-489f-9797-ac7c856202b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Discovery
• Version Model Number: MI
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• 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	00195278098603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161574

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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [Discovery]

• 00840682146166: MI Digital Ready
• 00840682143523: MI
• 00840682136709: XR656 HD Upgrade
• 00840682125703: IQ 2.0
• 00840682120975: MI Digital Ready
• 00840682108218: MI
• 00840682103107: IQ
• 00840682103053: PETCT 610
• 00840682102995: PETCT 710
• 00195278098603: PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make
• 00195278840226: XR656HD UDI Label