Ultrasound, Hyperthermia, Cancer Treatment

Device Code: 5437

Product Code(s): LSY

Device Classification Information

• Device Type ID: 5437
• Device Name: Ultrasound, Hyperthermia, Cancer Treatment
• 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: LSY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-275 IEC 61161 Edition 3.0 2013-01
  Ultrasonics -- Power Measurement -- Radiation Force Balances And Performance Requirements

Total Product Life Cycle

• Device Type ID: 5437
• Device: Ultrasound, Hyperthermia, Cancer Treatment
• Product Code: LSY
• FDA Device Classification: Class 3 Medical Device

TPLC Last Update: 2019-04-02 21:06:15