Cleared Traditional

K242681 - NUSONO Handheld Ultrasound Scanner (NUS...

Also marketed or referenced as:
NUSONO Handheld Ultrasound Scanner (NUSONO-L75) NUSONO Handheld Ultrasound Scanner (NUSONO-P25)

K242681 is an FDA 510(k) clearance for NUSONO Handheld Ultrasound Scanner (NUS..., manufactured by Nurodata, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K242681 · Nurodata, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
167d
Days
Class 2
Risk

K242681 is an FDA 510(k) clearance for the NUSONO Handheld Ultrasound Scanner (NUSONO-C35). 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 Nurodata, Inc. (Zhubei, TW). The FDA issued a Cleared decision on February 20, 2025 after a review of 167 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 Nurodata, Inc. devices

FDA 510(k) Submission Details - K242681

510(k) Number K242681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2024
Decision Date February 20, 2025
Days to Decision 167 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
60d slower than avg
Panel avg: 107d · This submission: 167d
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 889
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K242681.
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K243620 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 2025