Cleared Traditional

K161588 - Vscan Extend

K161588 is an FDA 510(k) clearance for Vscan Extend, manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K161588 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology device
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Aug 2016
Decision
84d
Days
Class 2
Risk

K161588 is an FDA 510(k) clearance for the Vscan Extend. 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 Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Wauwatosa, US). The FDA issued a Cleared decision on August 31, 2016 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC devices

FDA 510(k) Submission Details - K161588

510(k) Number K161588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2016
Decision Date August 31, 2016
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 873
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K161588.
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K162267 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2016
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K162094 · Samsung Medison Co., Ltd. · Aug 2016
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
K162045 · FUJIFILM Sonosite, Inc. · Aug 2016
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · Siemens Medical Solutions USA, Inc. · Jul 2016