Cleared Traditional

K123238 - ACHILLES

K123238 is an FDA 510(k) clearance for ACHILLES, manufactured by Ge Medical Systems China Co., Ltd.. The device is a Class 2 Radiology device with product code MUA cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K123238 · Ge Medical Systems China Co., Ltd. · Radiology device
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Feb 2013
Decision
132d
Days
Class 2
Risk

K123238 is an FDA 510(k) clearance for the ACHILLES. Classified as Bone Sonometer (product code MUA), Class II - Special Controls.

Submitted by Ge Medical Systems China Co., Ltd. (Wuxi, Jiangsu Province, CN). The FDA issued a Cleared decision on February 25, 2013 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1180 - 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 Ge Medical Systems China Co., Ltd. devices

FDA 510(k) Submission Details - K123238

510(k) Number K123238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2012
Decision Date February 25, 2013
Days to Decision 132 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
25d slower than avg
Panel avg: 107d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUA Device Classification - Class 2, Special Controls

Product Code MUA Bone Sonometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1180
Definition A Bone Sonometer Is A Device That Transmits Ultrasound Energy Into The Human Body To Measure Acoustic Properties Of Bone That Indicate Overall Bone Health And Fracture Risk. The Primary Components Of The Device Are A Voltage Generator, A Transmitting Transducer, A Receiving Transducer, And Hardware And Software For Reception And Processing Of The Received Ultrasonic Signal. Reclassified From Class 3 Pma To Class 2 510(k) 892.1180 [docket No. Fda-2005-n-0346] Reclassification Of Bone Sonometers
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.