Cleared Traditional

K133695 - TITAN 11 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.

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