Monitor, Ultrasonic, Nonfetal

Device Code: 5357

Product Code(s): JAF

Device Classification Information

• Device Type ID: 5357
• Device Name: Monitor, Ultrasonic, Nonfetal
• Regulation Description: Nonfetal Ultrasonic Monitor.
• 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: 892.1540 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JAF
• 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
• 12-316 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: 5357
• Device: Monitor, Ultrasonic, Nonfetal
• Product Code: JAF
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Nonfetal Ultrasonic Monitor.
• CFR Regulation Number: 892.1540 [🔎]

Premarket Reviews
Manufacturer	Decision
THD SPA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Sensing Problem	43
Adverse Event Without Identified Device Or Use Problem	1
Misassembly By Users	1
Total Device Problems	45

Recalls
Manufacturer		Recall Class	Date Posted
1	Natus Neurology Inc	II	Jul-13-2017

TPLC Last Update: 2019-04-02 21:04:52