Cleared Traditional

K133695 - TITAN 11

K133695 is an FDA 510(k) clearance for TITAN 11, manufactured by Gemss Medical Systems Co., Ltd.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K133695 · Gemss Medical Systems Co., Ltd. · Radiology device
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Aug 2014
Decision
247d
Days
Class 2
Risk

K133695 is an FDA 510(k) clearance for the TITAN 11. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Gemss Medical Systems Co., Ltd. (Houston, US). The FDA issued a Cleared decision on August 7, 2014 after a review of 247 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gemss Medical Systems Co., Ltd. devices

FDA 510(k) Submission Details - K133695

510(k) Number K133695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2013
Decision Date August 07, 2014
Days to Decision 247 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 107d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 206
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