Cleared Special

K072090 - SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS

K072090 is the FDA 510(k) clearance for SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS by Siemens Medical Solutions USA, Inc., Ultrasound DI. It is a Class 2 Radiology device (product code IYN) cleared through the Special 510(k) pathway after a 46-day FDA review.

K072090 · Siemens Medical Solutions USA, Inc., Ultrasound DI · Radiology device
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Sep 2007
Decision
46d
Days
Class 2
Risk

K072090 is an FDA 510(k) clearance for the SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI (Mountainview, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Medical Solutions USA, Inc., Ultrasound DI devices

Submission Details

510(k) Number K072090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2007
Decision Date September 14, 2007
Days to Decision 46 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 790
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