Cleared Special

K103645 - APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM

K103645 is an FDA 510(k) clearance for APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Toshiba Medical Systems Corporation, Japan. The device is a Class 2 Radiology device with product code ITX cleared through the Special 510(k) pathway after a 30-day FDA review.

K103645 · Toshiba Medical Systems Corporation, Japan · Radiology device
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Jan 2011
Decision
30d
Days
Class 2
Risk

K103645 is an FDA 510(k) clearance for the APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Toshiba Medical Systems Corporation, Japan (Tustin, US). The FDA issued a Cleared decision on January 12, 2011 after a review of 30 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 Toshiba Medical Systems Corporation, Japan devices

FDA 510(k) Submission Details - K103645

510(k) Number K103645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2010
Decision Date January 12, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
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 - ITX Transducer, Ultrasonic, Diagnostic

All 348
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