Cleared Abbreviated

K053325 - MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY) (FDA 510(k) Clearance)

Also includes:
MULTISCAN ULTRASOUND SYSTEM, MODEL M0001

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

K053325 · Mediwatch, Ltd. · Radiology device
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Dec 2005
Decision
6d
Days
Class 2
Risk

K053325 is an FDA 510(k) clearance for the MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY). Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Mediwatch, Ltd. (Warwickshire, GB). The FDA issued a Cleared decision on December 7, 2005 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mediwatch, Ltd. devices

Submission Details

510(k) Number K053325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2005
Decision Date December 07, 2005
Days to Decision 6 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 107d · This submission: 6d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

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