Cleared Traditional

K171579 - M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58...

K171579 is the FDA 510(k) clearance for M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58... 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 140-day FDA review.

K171579 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device
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Oct 2017
Decision
140d
Days
Class 2
Risk

K171579 is an FDA 510(k) clearance for the M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 18, 2017 after a review of 140 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 K171579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2017
Decision Date October 18, 2017
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
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

All 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K171579.
U50 Diagnostic Ultrasound System
K173003 · Edan Instruments, Inc. · Nov 2017
Vivid E80, Vivid E90, Vivid E95
K173341 · GE Medical Systems · Nov 2017
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
K172970 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2017
Voluson E6, Voluson E8, Voluson E10
K172342 · Ge Healthcare · Sep 2017
U2 Diagnostic Ultrasound System
K172380 · Edan Instruments, Inc. · Sep 2017
ZS3 Ultrasound System, z.one pro Ultrasound System
K171891 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2017