510(k) K072090

SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS by Siemens Medical Solutions USA, Inc., Ultrasound DI — Product Code IYN

K072090 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI for the device "SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS". The FDA issued a decision of Substantially Equivalent on Sep 14, 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
Sep 14, 2007
Date Received
Jul 30, 2007
Clearance Type
Special
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)