GUDID 00195278117021

SIGNA Artist System Medical Device Assembly-MDR

GE Medical Systems (Tianjin) Co., Ltd.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00195278117021
• NIH Device Record Key: 7c06694c-1dee-4a2a-83f4-ac99999bd572
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SIGNA Artist
• Company DUNS: 421356265
• Company Name: GE Medical Systems (Tianjin) Co., Ltd.
• 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: false
• 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	00195278117021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163331

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-20
• Device Publish Date: 2021-01-12

Devices Manufactured by GE Medical Systems (Tianjin) Co., Ltd.

• 00195278929518 - NA: 2025-10-06 SIGNA Sprint System Medical Device
• 00195278601162 - NA: 2025-04-23 SIGNA Prime Elite System Medical Device
• 00195278707871 - NA: 2024-02-13 SIGNA Champion System Medical Device
• 00195278629234 - NA: 2023-08-14 SIGNA Voyager 1.5T Detachable Table - Wireless Gating
• 00195278616845 - NA: 2023-03-20 SIGNA Victor System Medical Device
• 00195278481382 - NA: 2022-09-16 SIGNA Artist Evo System Medical Device, MDR
• 00840682146302 - NA: 2022-03-15 SIGNA Prime System Medical Device
• 00195278372307 - NA: 2021-06-23 Voyager AIR Medical Device Assembly