Cleared Special

K031894 - SCANTEC PAD (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031894 · Sonotech, Inc. · Radiology device
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Jul 2003
Decision
29d
Days
Class 2
Risk

K031894 is an FDA 510(k) clearance for the SCANTEC PAD. Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Sonotech, Inc. (Bellingham, US). The FDA issued a Cleared decision on July 18, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Sonotech, Inc. devices

Submission Details

510(k) Number K031894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2003
Decision Date July 18, 2003
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MUI Media, Coupling, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - MUI Media, Coupling, Ultrasound

All 32
Devices cleared under the same product code (MUI) and FDA review panel - the closest regulatory comparables to K031894.
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K241789 · Hony Medical Co., Ltd. · Jul 2024
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K232957 · Jianerkang Medical Co., Ltd. · Dec 2023