Cleared Traditional

K243178 - Digital Color Doppler Ultrasound Imaging System (Apogee C1) (FDA 510(k) Clearance)

Also includes:
Digital Color Doppler Ultrasound Imaging System (Apogee C2) Digital Color Doppler Ultrasound Imaging System (Apogee C3) Digital Color Doppler Ultrasound Imaging System (Apogee C5) Digital Color Doppler Ultrasound Imaging System (Apogee K1) Digital Color Doppler Ultrasound Imaging System (Apogee K2) Digital Color Doppler Ultrasound Imaging System (Apogee K3) Digital Color Doppler Ultrasound Imaging System (Apogee K5) Di

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

K243178 · Shantou Institute of Ultrasonic Instruments Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
182d
Days
Class 2
Risk

K243178 is an FDA 510(k) clearance for the Digital Color Doppler Ultrasound Imaging System (Apogee C1). 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 Shantou Institute of Ultrasonic Instruments Co., Ltd. (Shantou, CN). The FDA issued a Cleared decision on March 31, 2025 after a review of 182 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 Shantou Institute of Ultrasonic Instruments Co., Ltd. devices

Submission Details

510(k) Number K243178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date March 31, 2025
Days to Decision 182 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
75d slower than avg
Panel avg: 107d · This submission: 182d
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

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