DeviceClearance

Product code OUJ— Radiology

trophon2

Classification name
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Device class
Class 2
Regulation
21 CFR 892.1570
Advisory panel
Radiology
Total cleared
4
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code OUJ under 21 CFR 892.1570, via openFDA

Market context for product code OUJ

FDA has cleared 4 devices under product code OUJ between 2011 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OUJ

Adverse events under product code OUJ

product code OUJ
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OUJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.