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Device
applicator, hyperthermia, deep heating, ultrasound
Review Panel
Radiology
Product Code
LNB
Premarket Review
Office of Radiological Health
(OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type
PMA
Device Class
3
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Eligible
Implanted Device?
No
Life-Sustain/Support Device?
No
Recognized Consensus Standards
12-275 IEC 61161 Edition 3.0 2013-01
Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
12-281 IEC 60601-2-62 Edition 1.0 2013-07
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
Third Party Review
Not Third Party Eligible
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