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U.S. Department of Health and Human Services

Product Classification

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Device diagnostic ultrasonic transducer, robotic
Regulation Description Diagnostic ultrasonic transducer.
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 In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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