Cleared Traditional

K160162 - Voluson P6

K160162 is the FDA 510(k) clearance for Voluson P6 by Ge Healthcare. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K160162 · Ge Healthcare · Radiology device
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Apr 2016
Decision
90d
Days
Class 2
Risk

K160162 is an FDA 510(k) clearance for the Voluson P6, Voluson P8. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on April 26, 2016 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Healthcare devices

Submission Details

510(k) Number K160162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date April 26, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K160162.
TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
K161525 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2016
LOGIQ P9 and LOGIQ P7
K161047 · Ge Healthcare · May 2016
6200 Ultrasound System and 6250 Ultrasound System
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K160807 · Philips Ultrasound, Inc. · Apr 2016
Acclarix LX8 Diagnostic Ultrasound System
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LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
K160277 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 2016