Cleared Traditional

K260846 - Diagnostic Ultrasound System (MU9) (FDA 510(k) Clearance)

Also includes:
Diagnostic Ultrasound System (MU9S) Diagnostic Ultrasound System (MU9T) Diagnostic Ultrasound System (MU9 Exp) Diagnostic Ultrasound System (MU9 Pro) Diagnostic Ultrasound System (MU9 Super) Diagnostic Ultrasound System (MU9P) Diagnostic Ultrasound System (MU9A) Diagnostic Ultrasound System (MU7) Diagnostic Ultrasound System (MU7S) Diagnostic Ultrasound System (MU7T) Diagnostic Ultrasound System (MU7 Exp) Diagnostic Ultrasound System (MU7 Pro) Diagnos

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

K260846 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
56d
Days
Class 2
Risk

K260846 is an FDA 510(k) clearance for the Diagnostic Ultrasound System (MU9). 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 11, 2026 after a review of 56 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K260846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2026
Decision Date May 11, 2026
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 1169
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K260846.
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