RoseM

GUDID 08800018401903

The RSM 2430C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography), which intended to be used in radiographic film/screen systems in general-purpose diagnostic procedures. The system can be applied wherever traditional X-ray screen-film cassettes are currently used.

DRTECH Corporation

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector

• Primary Device ID: 08800018401903
• NIH Device Record Key: 59f351a1-473f-402e-81f9-64c58914c60b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RoseM
• Version Model Number: RSM 2430C
• Company DUNS: 689842626
• Company Name: DRTECH Corporation
• 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	08800018401903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170930

FDA Product Code

• MUE: Full Field Digital,System,X-Ray,Mammographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-08-04

On-Brand Devices [RoseM]

• 08800018401903: The RSM 2430C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography
• 08800018401606: The RSM 1824C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography