GUDID 00195278577238

SIGNA Creator System Medical Device for MDR

GE HEALTHCARE(TIANJIN) COMPANY LIMITED

Full-body MRI system, superconducting magnet

• Primary Device ID: 00195278577238
• NIH Device Record Key: 274c65c1-3f56-41ca-bdad-5377bf22728a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SIGNA Creator
• Company DUNS: 421356265
• Company Name: GE HEALTHCARE(TIANJIN) COMPANY LIMITED
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278577238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143251

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2026-01-30
• Device Publish Date: 2022-12-09

Devices Manufactured by GE HEALTHCARE(TIANJIN) COMPANY LIMITED

• 00195278577221 - NA: 2026-01-30 SIGNA Explorer System Medical Device for MDR
• 00195278577238 - NA: 2026-01-30SIGNA Creator System Medical Device for MDR
• 00195278577238 - NA: 2026-01-30 SIGNA Creator System Medical Device for MDR