MX50N

GUDID 08809241513087

Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)

WIDE corporation

Image display unit, colour

• Primary Device ID: 08809241513087
• NIH Device Record Key: 37d990e5-90ea-4234-8773-2b79b1e79a36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MX50N
• Version Model Number: MX50YQS
• Company DUNS: 688285899
• Company Name: WIDE corporation
• Device Count: 1
• DM Exempt: true
• 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	08809241513087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170781

FDA Product Code

• PGY: Display, Diagnostic Radiology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-10-24
• Device Publish Date: 2017-04-27

On-Brand Devices [MX50N]

• 08809241513087: Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis
• 08809241513018: Flat panel hi-resolution LCD monitor system for displaying digital medical images.