Cleared Traditional

K261585 - Diagnostic Ultrasound System (Nuewa A20W)

Also marketed or referenced as:
Diagnostic Ultrasound System (Nuewa A20) Diagnostic Ultrasound System (Nuewa A20 Exp) Diagnostic Ultrasound System (Nuewa A20 Elite) Diagnostic Ultrasound System (Nuewa A20Q) Diagnostic Ultrasound System (Nuewa A MV) Diagnostic Ultrasound System (Nuewa A Elite) Diagnostic Ultrasound System (Nuewa A MS) Diagnostic Ultrasound System (Nuewa A20 Premium) Diagnostic Ultrasound System (Nuewa A20 Plus) Diagnostic Ultrasound System (Nuewa A18

K261585 is an FDA 510(k) clearance for Diagnostic Ultrasound System (Nuewa A20W), manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K261585 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
156d
Days
Class 2
Risk

K261585 is an FDA 510(k) clearance for the Diagnostic Ultrasound System (Nuewa A20W). 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2026 after a review of 156 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.

FDA 510(k) Submission Details - K261585

510(k) Number K261585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2026
Decision Date October 16, 2026
Days to Decision 156 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
49d slower than avg
Panel avg: 107d · This submission: 156d
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 1186
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K261585.
Diagnostic Ultrasound System (Resona I10W)
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K261933 · GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · Oct 2026
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EVO X30 Diagnostic Ultrasound System
K263182 · Samsung Medison Co., Ltd. · Sep 2026
Vivid Explorer/Vivid Advanced/Vivid Focus
K261313 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 2026
K261585 · Diagnostic Ultrasound System (Nuewa A20W)
Download PDF FDA Summary Shenzhen Mindray Bio-…