FLAATZ

Basic Information

• Brand Name: FLAATZ
• Primary DI: 08800018404003
• Version / Model: FLAATZ 500
• Company Name: DRTECH Corporation
• Labeler DUNS: 689842626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 4
• Public Version Date: 2019-02-21
• Public Version Status: Update
• Public Device Record Key: c109763d-d1b1-442a-bc55-3f7e334b6e84

Device Description

The FLAATZ 500 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPR	System, X-Ray, Stationary	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61109	Diagnostic x-ray digital imaging conversion system	An assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. Following acquisition the system is intended to also process, view, and/or store patient images as part of picture archiving and communication. It does not contain the controls for the direct operation of an x-ray imaging system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800018404003	GS1