Cleared Special

K111583 - FLAATZ 560 (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K111583 · Drtech Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
119d
Days
Class 2
Risk

K111583 is an FDA 510(k) clearance for the FLAATZ 560. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Drtech Corp. (Seongnam-Shi, Gyeonggi-Do, KR). The FDA issued a Cleared decision on October 4, 2011 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Drtech Corp. devices

Submission Details

510(k) Number K111583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2011
Decision Date October 04, 2011
Days to Decision 119 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 107d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 420
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K111583.
Lux HD 2530 detector (Lux HD 2530)
K252911 · Iray Imaging Technology (Haining) Limited · Oct 2025
Yushan X-Ray Flat Panel Detector
K250211 · Innocare Optoelectronics Corp. · Jul 2025
SKR 3000
K250665 · Konica Minolta, Inc. · Jun 2025
Wireless/ Wired X-Ray Flat Panel Detectors
K243734 · Allengers Medical Systems Limited · Apr 2025
EXPD 114
K242770 · DRTECH Corporation · Mar 2025
EXPD 4343N1
K243443 · DRTECH Corporation · Mar 2025