510(k) K050167

CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE by Chison Medical Imaging Co., Ltd. — Product Code IYO

K050167 is an FDA 510(k) premarket notification submitted by Chison Medical Imaging Co., Ltd. for the device "CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE". The FDA issued a decision of Substantially Equivalent on Feb 8, 2005. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Chison Medical Imaging Co., Ltd. has 12 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 8, 2005
Date Received
Jan 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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