Titan 11

FDA 510(k) K133695 · Gemss Medical Systems Co., Ltd.

Substantially Equivalent

510(k) numberK133695

Submission

Device name
Titan 11
Applicant
Gemss Medical Systems Co., Ltd.
Houston, TX, US
Received
December 3, 2013
Decision date
August 7, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPR – System, X-Ray, Stationary
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1680
Specialty
Radiology

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Questions and answers

When was Titan 11 cleared by the FDA?

Titan 11 (K133695) received a 510(k) decision of Substantially Equivalent on August 7, 2014, 247 days after the submission was received.

What is the product code of K133695?

The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.