Identifiers
- 510(k) Number
- K111655 FDA 510(k)
- FDA Product Code
- KPR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flaatz 760 is a stationary X-ray system flat panel detector, designed for high-volume radiography applications. It features a radiography flat panel detector with advanced temperature stability and uniform coating technology to ensure consistent image quality even after extensive use.
This device is intended for use in radiology settings and is supplied as a reusable, non-sterile medical device. It is classified as a Class II device under FDA regulations (21 CFR 892.1680) and holds a Special 510(k) clearance (K111655) with a decision date of November 30, 2011. The device is MRI-unsafe and requires proper storage and handling as specified by the manufacturer.
Frequently asked questions
What types of radiology settings is the Flaatz 760 designed for, and how does its technology ensure consistent image quality over time?
The Flaatz 760 is specifically designed for high-volume radiography applications in radiology settings. Its advanced temperature stability and uniform coating technology help maintain consistent image quality, even after prolonged or extensive use. This makes it suitable for busy departments where reliability and performance are critical.
Is the Flaatz 760 a single-use or reusable device, and what does that mean for maintenance and cleaning?
The Flaatz 760 is a reusable, non-sterile medical device. This means it is intended to be cleaned and maintained according to the manufacturer’s instructions between uses, rather than being discarded after a single procedure. Proper cleaning and handling are essential to ensure its longevity and performance.
Can the Flaatz 760 be used in an MRI environment, and what storage or handling precautions should be taken?
The Flaatz 760 is explicitly labeled as MRI-unsafe, meaning it should never be used or stored within an MRI environment. The manufacturer specifies proper storage and handling to ensure safety and functionality, so follow their guidelines to avoid interference with MRI systems or damage to the device.
What regulatory pathway was followed for the Flaatz 760, and what does that mean for its use in clinical settings?
The Flaatz 760 underwent a Special 510(k) review through the FDA’s Radiology (RA) Advisory Committee, receiving clearance under K111655 on November 30, 2011. This classification as a Class II device (21 CFR 892.1680) indicates it has been deemed substantially equivalent to a predicate device and meets FDA requirements for safety and effectiveness. Clinicians can rely on this regulatory pathway as evidence of its compliance with U.S. standards.
How does the Flaatz 760’s design support high-volume radiography, and what features contribute to its durability?
The Flaatz 760 is engineered for high-volume radiography with a radiography flat panel detector that emphasizes temperature stability and uniform coating technology. These features help prevent degradation in image quality over time, ensuring consistent performance even with frequent use. Its reusable design further supports efficiency in high-throughput environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DRTECH, FLAATZ FLAATZ 760 by DRTECH - Komachine Supplier Profile and Product List, Multipurpose radiography flat panel detector - FLAATZ 760 - DRTECH - 17 ..., FLAATZ FLAATZ 760 by DRTECH - Komachine Supplier Profile and Product List
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111655 | Class II | Active |
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Manufacturer
- Manufacturer
- Drtech Corp.
Sources (1)
- FDA 510(k) K111655 24 fields · synced Sep 19, 2026