Media, Coupling, Ultrasound

Device Code: 5395

Product Code(s): MUI

Device Classification Information

• Device Type ID: 5395
• Device Name: Media, Coupling, Ultrasound
• Regulation Description: Diagnostic Ultrasonic Transducer.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 892.1570 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MUI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 12-105 NEMA UD 2-2004 (R2009)
  Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3
• 12-293 IEC 60601-2-37 Edition 2.1 2015
  Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment
• 12-316 IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION
  Ultrasonics - Field Characterization - Test Methods For The Determination Of Thermal And Mechanical Indices Related To Medical Diagnostic Ultrasonic Fields

Total Product Life Cycle

• Device Type ID: 5395
• Device: Media, Coupling, Ultrasound
• Product Code: MUI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Diagnostic Ultrasonic Transducer.
• CFR Regulation Number: 892.1570 [🔎]

Premarket Reviews
Manufacturer	Decision
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHARMACEUTICAL INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	3
QUOTIENT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 21:05:30