CW120N

GUDID 08809241513124

CW120N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.

WIDE corporation

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• Primary Device ID: 08809241513124
• NIH Device Record Key: 2b7dd737-774f-4d67-9b02-656e7443edfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CW120N
• Version Model Number: CW120N
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809241513124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210491

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: 2
• Public Version Date: 2022-10-24
• Device Publish Date: 2021-04-20

Devices Manufactured by WIDE corporation

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• 08809241513049 - CX30N: 2022-10-24 Flat panel hi-resolution LCD monitor system for displaying digital medical images.
• 08809241513056 - CX20N: 2022-10-24 Flat panel hi-resolution LCD monitor system for displaying digital medical images.
• 08809241513063 - 6MP: 2022-10-24 Flat Panel hi-resolution LCD monitor system for displaying digital medical images.
• 08809241513070 - CX50N: 2022-10-24 Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)