High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
The High Level Disinfection Reprocessing Instrument for Ultrasonic Transducers, Mist (product code OUJ) is a device designed to provide high-level disinfection of ultrasound transducers using a mist-based delivery system. It ensures that reusable ultrasound probes meet disinfection requirements before reuse on patients. As an FDA Class 2 device under regulation 892.1570, it requires 510(k) premarket clearance and falls within the Radiology specialty, reviewed by the General Hospital panel. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OUJ
- Device Class
- FDA class 2
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250434 | trophon2 | Aug 05, 2025 | Substantially Equivalent | Nanosonics |
| K241536 | trophon Wireless Ultrasound Probe Holder | Sep 27, 2024 | Substantially Equivalent | Nanosonics Limited |
| K173865 | trophon2 | Apr 24, 2018 | Substantially Equivalent | Nanosonics Limited |
| K103059 | TROPHON | Feb 24, 2011 | Substantially Equivalent | Nanosonics Limited |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.