Cleared Traditional

K170445 - LOGIQ S8

K170445 is an FDA 510(k) clearance for LOGIQ S8, 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 56-day FDA review.

K170445 · Ge Healthcare · Radiology device
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Apr 2017
Decision
56d
Days
Class 2
Risk

K170445 is an FDA 510(k) clearance for the LOGIQ S8. 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 11, 2017 after a review of 56 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 - K170445

510(k) Number K170445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2017
Decision Date April 11, 2017
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 1098
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K170445.
Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley
K170078 · Medisono, LLC · May 2017
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K163690 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2017
Interson USB Ultrasound System
K163443 · Interson Corporation · Apr 2017
Acuson SC2000 Diagnostic Ultrasound System
K170315 · Siemens Medi Cal Solutions, Inc. · Apr 2017
HS50 / HS60 Diagnostic Ultrasound System
K170493 · Samsung Medison Co., Ltd. · Mar 2017
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
K170277 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2017