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U.S. Department of Health and Human Services

Product Classification

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Device high level disinfection reprocessing instrument for ultrasonic transducers, liquid
Regulation Description Diagnostic ultrasonic transducer.
Definition To provide high level disinfection of ultrasound transducers If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Physical State ultrasonic transducer reprocessor, high level disinfectant liquid, and accessories
Technical Method Automatically delivers liquid disinfectant and exposes a suspended ultrasound transducer to the disinfectant at a specified temperature and for a specified time to achieve high level disinfection and then rinses the ultrasound transducer with water to remove the disinfectant
Target Area Ultrasonic transducers
Regulation Medical Specialty Radiology
Review Panel General Hospital
Product CodePSW
Premarket Review Infection Control and Plastic Surgery Devices (DHT4B)
Infection Control and Plastic Surgery Devices (DHT4B)
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
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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