510(k) K140729

APLIO ARTIDA, V3.2 by Toshiba America Medical Systems, In.C — Product Code IYN

K140729 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "APLIO ARTIDA, V3.2". The FDA issued a decision of Substantially Equivalent on May 23, 2014. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2014
Date Received
March 24, 2014
Clearance Type
Traditional
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