Cleared Traditional

K201059 - S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System

K201059 is an FDA 510(k) clearance for S60 Elite Series/S70 Series Digital Col..., manufactured by Sonoscape Medical Corp.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K201059 · Sonoscape Medical Corp. · Radiology device
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Jul 2020
Decision
100d
Days
Class 2
Risk

K201059 is an FDA 510(k) clearance for the S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System. 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 Sonoscape Medical Corp. (Shenzhen, CN). The FDA issued a Cleared decision on July 30, 2020 after a review of 100 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 Sonoscape Medical Corp. devices

FDA 510(k) Submission Details - K201059

510(k) Number K201059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2020
Decision Date July 30, 2020
Days to Decision 100 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
7d faster than avg
Panel avg: 107d · This submission: 100d
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 1097
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K201059.
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System
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K201693 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2020
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