Cross-sectional Mammographic Xray System

Device Code: 5444

Product Code(s): OLQ

Definition: Diagnostic Breast Imaging. Imaging Of The Breast By Cross-sectional X-ray Imaging For Diagnostic Purposes.

Device Classification Information

• Device Type ID: 5444
• Device Name: Cross-sectional Mammographic Xray System
• Physical State: Medical Diagnostic X-ray Imaging System
• Technical Method: X-ray Imaging
• Target Area: Breast
• 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: OLQ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5444
• Device: Cross-sectional Mammographic Xray System
• Product Code: OLQ
• FDA Device Classification: Class 3 Medical Device

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