Cleared Traditional

K121010 - M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

K121010 is the FDA 510(k) clearance for M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM 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 16-day FDA review.

K121010 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
16d
Days
Class 2
Risk

K121010 is an FDA 510(k) clearance for the M7/M7T 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, Baimang, Xili Town, CN). The FDA issued a Cleared decision on April 19, 2012 after a review of 16 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 K121010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2012
Decision Date April 19, 2012
Days to Decision 16 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K121010.
MYLABSOGNO
K121384 · Esaote, S.P.A. · May 2012
VOLUSON S6, VOLUSON S8
K120741 · Ge Healthcare · Apr 2012
DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
K120699 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2012
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM
K113381 · Samsung Medison Co., Ltd. · Dec 2011
GE LOGIQ I, LOGIQ E AND VIVID E
K113690 · Ge Healthcare · Dec 2011
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
K113647 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2011