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510(k) Data Aggregation
K Number
K141010Device Name
M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD
Date Cleared
2014-05-14
(26 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M9/M9CV/M9T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel , urology exams.
Device Description
M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, PW-Mode, Color-Mode , Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
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