510(k) K131305

CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE by Chison Medical Imaging Co., Ltd. — Product Code IYN

K131305 is an FDA 510(k) premarket notification submitted by Chison Medical Imaging Co., Ltd. for the device "CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE". The FDA issued a decision of Substantially Equivalent on Aug 1, 2013. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Chison Medical Imaging Co., Ltd. has 12 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 1, 2013
Date Received
May 7, 2013
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
510(k)