Cleared Special

K111655 - FLAATZ 760

K111655 is an FDA 510(k) clearance for FLAATZ 760, manufactured by Drtech Corp.. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 170-day FDA review.

K111655 · Drtech Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
170d
Days
Class 2
Risk

K111655 is an FDA 510(k) clearance for the FLAATZ 760. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Drtech Corp. (Seongnam-Shi, Gyeonggi-Do, KR). The FDA issued a Cleared decision on November 30, 2011 after a review of 170 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K111655

510(k) Number K111655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2011
Decision Date November 30, 2011
Days to Decision 170 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 107d · This submission: 170d
Pathway characteristics
Modification to existing cleared device.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
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 - KPR System, X-ray, Stationary

All 320
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