AIDIA

GUDID 08800018423004

The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast cancer. This unit is intended for use in the same clinical applications as traditional screen film mammography systems.

DRTECH Corporation

Stationary mammographic x-ray system, digital

• Primary Device ID: 08800018423004
• NIH Device Record Key: 7bca2c13-0c59-4f80-9b0d-6efed79282a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIDIA
• Version Model Number: RMF-2000
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800018423004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220073

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-23
• Device Publish Date: 2023-06-15

Devices Manufactured by DRTECH Corporation

• 08800018422502 - LLD 86 Basic: 2024-05-16 The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
• 08800018421307 - LLD 129 Basic: 2023-11-13 The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
• 08800018421406 - LLD 129 without rotation: 2023-11-13 The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone.
• 08800018407905 - EXPD 4357: 2023-09-12
• 08800018408001 - EXPD 4357P: 2023-09-12
• 08800018421208 - DBS-57M: 2023-09-12
• 08800018420805 - EXTRON 5: 2023-09-01
• 08800018420904 - EXTRON 7: 2023-09-01