510(k) K233734

Interson USB Ultrasound System by Interson Corporation — Product Code IYN

K233734 is an FDA 510(k) premarket notification submitted by Interson Corporation for the device "Interson USB Ultrasound System". The FDA issued a decision of Substantially Equivalent on December 22, 2023. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Interson Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2023
Date Received
November 22, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type