Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1570](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1570) → OUJ — High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

# OUJ · High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

_Radiology · 21 CFR 892.1570 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OUJ

## Overview

- **Product Code:** OUJ
- **Device Name:** High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
- **Regulation:** [21 CFR 892.1570](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1570)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250434](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OUJ/K250434.md) | trophon2 | Nanosonics | Aug 5, 2025 | SESE |
| [K241536](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OUJ/K241536.md) | trophon Wireless Ultrasound Probe Holder | Nanosonics Limited | Sep 27, 2024 | SESE |
| [K173865](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OUJ/K173865.md) | trophon2 | Nanosonics Limited | Apr 24, 2018 | SESE |
| [K103059](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OUJ/K103059.md) | TROPHON | Nanosonics Limited | Feb 24, 2011 | SESE |

## Top Applicants

- Nanosonics Limited — 3 clearances
- Nanosonics — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OUJ](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OUJ)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com