Cleared Traditional

K092164 - TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA (FDA 510(k) Clearance)

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

K092164 · Shenzhen Delicate Electronics Co., Ltd. · Radiology device
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May 2010
Decision
301d
Days
Class 2
Risk

K092164 is an FDA 510(k) clearance for the TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS.... Classified as Diagnostic Ultrasonic Transducer, Robotic (product code OQQ), Class II - Special Controls.

Submitted by Shenzhen Delicate Electronics Co., Ltd. (Yonkers, US). The FDA issued a Cleared decision on May 13, 2010 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K092164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2009
Decision Date May 13, 2010
Days to Decision 301 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
194d slower than avg
Panel avg: 107d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OQQ Diagnostic Ultrasonic Transducer, Robotic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
Definition Diagnostic Ultrasonic Imaging Or Monitoring.
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.