510(k) K141093

6VT-D ULTRASOUND TRANSDUCER by Ge Vingmed Ultrasound AS — Product Code ITX

K141093 is an FDA 510(k) premarket notification submitted by Ge Vingmed Ultrasound AS for the device "6VT-D ULTRASOUND TRANSDUCER". The FDA issued a decision of Substantially Equivalent on May 15, 2014. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Ge Vingmed Ultrasound AS has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2014
Date Received
April 28, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type