510(k) K241536

Device

trophon Wireless Ultrasound Probe Holder

Applicant

Nanosonics Limited

510(k) number

K241536

Product code

OUJ

Decision

Substantially Equivalent (SESE)

Decision date

2024-09-27

Date received

2024-05-30

Regulation

892.1570

Classification name

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Medical specialty

Radiology

Review panel

Radiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No