Cleared Traditional

NUSONO Handheld Ultrasound Scanner (NUSONO-C35) (K242681) - FDA 510(k) Clearance

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

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 633
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K242681.
EPIQ Series Diagnostic Ultrasound System
K250177 · Philips Ultrasound, LLC · Apr 2025
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System
K243298 · Carbon (Shenzhen) Medical Device Co., Ltd. · Apr 2025
Digital Color Doppler Ultrasound Imaging System (Apogee C1)
K243178 · Shantou Institute of Ultrasonic Instruments Co., Ltd. · Mar 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
K250214 · Edan Instruments, Inc. · Feb 2025
V8 Diagnostic Ultrasound System
K243702 · Samsung Medison Co., Ltd. · Feb 2025
Vivid iq
K243620 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 2025