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- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- PUPEndoscope Maintenance System2Product Code
- FEBAccessories, Cleaning, For Endoscope2Product Code
- NVEWasher, Cleaner, Automated, Endoscope2Product Code
- NZAAccessories, Germicide, Cleaning, For Endoscopes2Product Code
- OUJHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist2Product Code
- PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid2Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
- Page Type
- Product Code
- 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
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 892.1570
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 892.1570 Diagnostic ultrasonic transducer
§ 892.1570 Diagnostic ultrasonic transducer.
(a) Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
(b) Classification. Class II.