510(k) K132736

ACCURO 3000 ULTRASOUND SCANNER by Rivanna Medical, LLC — Product Code IYO

K132736 is an FDA 510(k) premarket notification submitted by Rivanna Medical, LLC for the device "ACCURO 3000 ULTRASOUND SCANNER". The FDA issued a decision of Substantially Equivalent on March 11, 2014. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Rivanna Medical, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2014
Date Received
September 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type