Cleared Special

K170315 - Acuson SC2000 Diagnostic Ultrasound System

K170315 is the FDA 510(k) clearance for Acuson SC2000 Diagnostic Ultrasound System by Siemens Medi Cal Solutions, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Special 510(k) pathway after a 62-day FDA review.

K170315 · Siemens Medi Cal Solutions, Inc. · Radiology device
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Apr 2017
Decision
62d
Days
Class 2
Risk

K170315 is an FDA 510(k) clearance for the Acuson SC2000 Diagnostic 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 Medi Cal Solutions, Inc. (Moutain View, US). The FDA issued a Cleared decision on April 4, 2017 after a review of 62 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 Medi Cal Solutions, Inc. devices

Submission Details

510(k) Number K170315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2017
Decision Date April 04, 2017
Days to Decision 62 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 107d · This submission: 62d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 780
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