Optima

GUDID 00840682116510

GE HEALTHCARE JAPAN CORPORATION

Full-body CT system

• Primary Device ID: 00840682116510
• NIH Device Record Key: 813a882d-9fa3-4384-8dcd-6bb8b66514a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optima
• Version Model Number: CT660 Cj2.5 Upgrade
• Company DUNS: 696021596
• Company Name: GE HEALTHCARE JAPAN CORPORATION
• 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: 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	00840682116510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131576

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: 2016-06-10

Devices Manufactured by GE HEALTHCARE JAPAN CORPORATION

• 00195278620453 - DLIR: 2023-07-10 SWMD DLIR Application for Smart Subscription
• 00195278303196 - ASiR-V: 2021-09-02 ASiR-V Application Container for Smart Subscription
• 00195278303202 - DLIR: 2021-09-02 DLIR Application Container for Smart Subscription
• 00195278303219 - MAR: 2021-09-02 MAR Application Container for Smart Subscription
• 00840682146173 - Revolution: 2020-12-04 NGX Gantry common top asm with UDI
• 00840682110181 - NA: 2020-05-05
• 00840682146586 - DLIR: 2020-03-02
• 00840682125826 - NA: 2019-12-23