Cleared Special

K080760 - ACUSON X300 ULTRASOUND SYSTEM

K080760 is the FDA 510(k) clearance for ACUSON X300 ULTRASOUND SYSTEM 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 38-day FDA review.

K080760 · Siemens Medical Solutions USA, Inc., Ultrasound DI · Radiology device
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Apr 2008
Decision
38d
Days
Class 2
Risk

K080760 is an FDA 510(k) clearance for the ACUSON X300 ULTRASOUND SYSTEM. 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 April 25, 2008 after a review of 38 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 K080760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2008
Decision Date April 25, 2008
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
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 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K080760.
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