Cleared Traditional

K261288 - Handheld Ultrasound Scanner

K261288 is an FDA 510(k) clearance for Handheld Ultrasound Scanner, manufactured by IMGFAX CO., LTD.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K261288 · IMGFAX CO., LTD. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2026
Decision
101d
Days
Class 2
Risk

K261288 is an FDA 510(k) clearance for the Handheld Ultrasound Scanner. 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 IMGFAX CO., LTD. (Foshan, CN). The FDA issued a Cleared decision on July 30, 2026 after a review of 101 days - within the typical 510(k) review window.

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 IMGFAX CO., LTD. devices

FDA 510(k) Submission Details - K261288

510(k) Number K261288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2026
Decision Date July 30, 2026
Days to Decision 101 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
6d faster than avg
Panel avg: 107d · This submission: 101d
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 Consultant

Imd Medical & Drug Technology Service Institutions
Chen Salon

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1084
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K261288.
Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
K254027 · Sonoscape Medical Corp. · Aug 2026
Venue Go
K261668 · GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · Aug 2026
Alturion Series Diagnostic Ultrasound System
K262311 · Philips Ultrasound, LLC · Aug 2026
LOGIQ Focus
K261835 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 2026
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System
K261412 · Samsung Medison Co., Ltd. · Jul 2026
Philips EPIQ Series Diagnostic Ultrasound System
K261211 · Philips Ultrasound, LLC · Jul 2026