XVISION-525

GUDID 08800098700040

GEMSS Healthcare Co., Ltd.

Stationary basic diagnostic x-ray system, analogue

• Primary Device ID: 08800098700040
• NIH Device Record Key: 876ae5d0-a856-4f9f-bdc1-d7f0c9d62c23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XVISION-525
• Version Model Number: XVISION-525
• Company DUNS: 694184465
• Company Name: GEMSS Healthcare Co., Ltd.
• 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	08800098700040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230800

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2026-01-26
• Device Publish Date: 2026-01-16

Devices Manufactured by GEMSS Healthcare Co., Ltd.

• 08800098700040 - XVISION-525: 2026-01-26
• 08800098700040 - XVISION-525: 2026-01-26
• 08800098700156 - XPLUS 35 Series: 2026-01-26
• 08800098700163 - XPLUS 35 Series: 2026-01-26