510(k) K072365

SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM by Siemens Medical Solutions USA, Inc., Ultrasound DI — Product Code IYN

K072365 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI for the device "SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 17, 2007. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Siemens Medical Solutions USA, Inc., Ultrasound DI has 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 17, 2007
Date Received
Aug 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type
510(k)