510(k) K861237

VASOVIEW DUPLEX IMAGING SYSTEM by Sonicaid, Inc. — Product Code ITX

K861237 is an FDA 510(k) premarket notification submitted by Sonicaid, Inc. for the device "VASOVIEW DUPLEX IMAGING SYSTEM". The FDA issued a decision of SN on July 14, 1986. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Sonicaid, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 14, 1986
Date Received
April 2, 1986
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