# Flaatz 760

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/flaatz-760-kpr>
- Manufacturer: [Drtech Corp.](https://devicerts.com/manufacturers/drtech-corp) (South Korea)
- Name in the registry: FLAATZ 760
- Device class: Class II (US FDA)
- FDA product code: KPR

## Overview

*AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K111655 · decision 2011-11-30 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K111655 [FDA 510(k)]
- FDA product code: KPR [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1680 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Flaatz 760, Drtech Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/flaatz-760-kpr (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/flaatz-760-kpr.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/flaatz-760-kpr
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.