Product Classification

• Device: high level disinfection reprocessing instrument for ultrasonic transducers, mist
• 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 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 Code: OUJ
• Premarket Review: Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B); Infection Control and Plastic and Reconstructive 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc