Cleared Traditional

K250020 - Diagnostic Ultrasound System (Recho R9W)

Also marketed or referenced as:
Diagnostic Ultrasound System (Recho R9) Diagnostic Ultrasound System (Recho R9 Pro) Diagnostic Ultrasound System (Recho R9 Exp) Diagnostic Ultrasound System (Recho R9S) Diagnostic Ultrasound System (Recho R9T) Diagnostic Ultrasound System (Crius R9 CV) Diagnostic Ultrasound System (Anesus R9 CV) Diagnostic Ultrasound System (Recho R9 Super) Diagnostic Ultrasound System (Recho R9 Lumi) Diagnostic Ultrasound System (Recho R CV) Diagnost

K250020 is the FDA 510(k) clearance for Diagnostic Ultrasound System (Recho R9W) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K250020 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
136d
Days
Class 2
Risk

K250020 is an FDA 510(k) clearance for the Diagnostic Ultrasound System (Recho R9W). 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 May 19, 2025 after a review of 136 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K250020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2025
Decision Date May 19, 2025
Days to Decision 136 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
29d slower than avg
Panel avg: 107d · This submission: 136d
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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