RConsole1

GUDID 08800018411001

The Rconsole1 is intended for use with mammographic images acquired using digital breast x-ray systems.

DRTECH Corporation

Radiology DICOM image processing application software

• Primary Device ID: 08800018411001
• NIH Device Record Key: c652d295-7c5c-427f-b1d4-07089be35f02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RConsole1
• Version Model Number: 1.0
• 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	08800018411001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162670

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2019-10-07
• Device Publish Date: 2017-08-04

Devices Manufactured by DRTECH Corporation

• 08800018408506 - EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG: 2025-04-04
• 08800018408605 - EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG: 2025-04-04
• 08800018408704 - EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG: 2025-04-04
• 08800018408803 - EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG: 2025-04-04
• 08800018421505 - EXSYS DEXi: 2025-04-02
• 08800018421604 - EXSYS DEXi: 2025-04-02
• 08800018421703 - EXSYS DEXi: 2025-04-02
• 08800018421802 - EXSYS DEXi: 2025-04-02