FLAATZ

GUDID 08800018403808

The FLAATZ 560 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.

DRTECH Corporation

Diagnostic x-ray digital imaging conversion system

• Primary Device ID: 08800018403808
• NIH Device Record Key: d4b71169-e212-4ccc-891f-ffd5b2516cb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLAATZ
• Version Model Number: FLAATZ 560
• 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: false
• 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	08800018403808 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111583

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2026-03-20
• Device Publish Date: 2016-09-02

Devices Manufactured by DRTECH Corporation

• 08800018403808 - FLAATZ: 2026-03-20The FLAATZ 560 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
• 08800018403808 - FLAATZ: 2026-03-20 The FLAATZ 560 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbe
• 08800018422601 - EXTRON 3: 2025-06-25
• 08800018430002 - EXPD-N series: 2025-06-23
• 08800018430101 - EXPD-N series: 2025-06-23
• 08800018430200 - EXPD-N series: 2025-06-23
• 08800018430309 - EXPD-N series: 2025-06-23
• 08800018430408 - EXPD-N series: 2025-06-23
• 08800018430507 - EXPD-N series: 2025-06-23