Analyzer, Medical Image

Device Code: 5440

Product Code(s): MYN

Device Classification Information

• Device Type ID: 5440
• Device Name: Analyzer, Medical Image
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: MYN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-292 IEEE Std 3333.2.1-2015
  IEEE Recommended Practice For Three-Dimensional (3D) Medical Modeling

Total Product Life Cycle

• Device Type ID: 5440
• Device: Analyzer, Medical Image
• Product Code: MYN
• FDA Device Classification: Class 3 Medical Device

Device Problems
Problem With Software Installation	1
Total Device Problems	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GA Industries	II	Apr-27-2015

TPLC Last Update: 2019-04-02 21:06:17