Cleared Special

K130308 - NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM

K130308 is an FDA 510(k) clearance for NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM, manufactured by Hitachi Aloka Medical, Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 57-day FDA review.

K130308 · Hitachi Aloka Medical, Ltd. · Radiology device
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Apr 2013
Decision
57d
Days
Class 2
Risk

K130308 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 Aloka Medical, Ltd. (Wallingford, US). The FDA issued a Cleared decision on April 5, 2013 after a review of 57 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hitachi Aloka Medical, Ltd. devices

FDA 510(k) Submission Details - K130308

510(k) Number K130308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2013
Decision Date April 05, 2013
Days to Decision 57 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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

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