Cleared Traditional

K160559 - NOBLUS Ultrasound Diagnostic System

K160559 is an FDA 510(k) clearance for NOBLUS Ultrasound Diagnostic System, manufactured by Hitachi Medical Corporation. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K160559 · Hitachi Medical Corporation · Radiology device
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Oct 2016
Decision
232d
Days
Class 2
Risk

K160559 is an FDA 510(k) clearance for the NOBLUS™ Ultrasound Diagnostic System. 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 Hitachi Medical Corporation (Wallingford, US). The FDA issued a Cleared decision on October 18, 2016 after a review of 232 days - an extended review 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: 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 Hitachi Medical Corporation devices

FDA 510(k) Submission Details - K160559

510(k) Number K160559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date October 18, 2016
Days to Decision 232 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
125d slower than avg
Panel avg: 107d · This submission: 232d
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 922
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K160559.
Xperius Ultrasound System
K163020 · Philips Health Care · Nov 2016
Xario 200 Diagnostic Ultrasound System V5.0
K162155 · Toshibamedical Systems Corporation · Nov 2016
Ultrasound System SONIMAGE HS1
K162065 · Konica Minolta, Inc. · Oct 2016
MyLabSix CrystaLine
K162290 · Esaote, S.P.A. · Oct 2016
RS80A Diagnostic Ultrasound System
K153539 · Samsung Medison Co., Ltd. · Oct 2016
Voluson E6, Voluson E8, Voluson E10
K162269 · Ge Healthcare · Oct 2016