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U.S. Department of Health and Human Services

Product Classification

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Device diagnostic ultrasonic transducer, robotic
Definition Diagnostic ultrasonic imaging or monitoring.
Physical State piezoelectric material
Technical Method Robotic component maintains signal and recovers lost signal.
Target Area Unspecified
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeOQQ
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.1570
Device Class 2
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 Standard
Third Party Review
Accredited Persons
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