Cleared Traditional

K172342 - Voluson E6, Voluson E8, Voluson E10

K172342 is an FDA 510(k) clearance for Voluson E6, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K172342 · Ge Healthcare · Radiology device
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Sep 2017
Decision
58d
Days
Class 2
Risk

K172342 is an FDA 510(k) clearance for the Voluson E6, Voluson E8, Voluson E10. 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 September 29, 2017 after a review of 58 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 Healthcare devices

FDA 510(k) Submission Details - K172342

510(k) Number K172342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2017
Decision Date September 29, 2017
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
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 1097
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K172342.
SONON Ultrasound Imaging System, Model: 300L
K170085 · Healcerion Co., Ltd. · Oct 2017
LinkQuest Diagnostic Ultrasound System model SQ860
K172059 · Linkquest, Inc. · Oct 2017
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
K172607 · Philips Health Care · Oct 2017
U2 Diagnostic Ultrasound System
K172380 · Edan Instruments, Inc. · Sep 2017
ZS3 Ultrasound System, z.one pro Ultrasound System
K171891 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2017
S60 Series Digital Color Doppler Ultrasound System
K172082 · Sonoscape Medical Corp. · Sep 2017