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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, mist
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 mist, and accessories
Technical Method Automatically generates a mist from a dedicated hydrogen peroxide disinfectant solution and exposes a suspended ultrasound transducer to the disinfectant mist at a specified temperature and for a specified time to achieve high level disinfection
Target Area Ultrasonic transducers
Regulation Medical Specialty Radiology
Review Panel General Hospital
Product CodeOUJ
Premarket Review Surgical and Infection Control Devices (OHT4)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons