Cleared Traditional

Digital Color Doppler Ultrasound Imaging System (Readius L15) (K243132) - FDA 510(k) Clearance

Also marketed or referenced as:
Digital Color Doppler Ultrasound Imaging System (Readius P8) Digital Color Doppler Ultrasound Imaging System (Readius V6) Digital Color Doppler Ultrasound Imaging System (Readius C6)

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

K243132 · Shantou Institute of Ultrasonic Instruments Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
71d
Days
Class 2
Risk

K243132 is an FDA 510(k) clearance for the Digital Color Doppler Ultrasound Imaging System (Readius L15). 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 December 10, 2024 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shantou Institute of Ultrasonic Instruments Co., Ltd. devices

Submission Details

510(k) Number K243132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date December 10, 2024
Days to Decision 71 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 107d · This submission: 71d
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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