Cleared Traditional

K182596 - Xario200G and Xario100G

K182596 is the FDA 510(k) clearance for Xario200G and Xario100G by Canon Medical Systems Corporation. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K182596 · Canon Medical Systems Corporation · Radiology device
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Nov 2018
Decision
43d
Days
Class 2
Risk

K182596 is an FDA 510(k) clearance for the Xario200G and Xario100G, Software V1.1 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 Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on November 2, 2018 after a review of 43 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Canon Medical Systems Corporation devices

Submission Details

510(k) Number K182596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2018
Decision Date November 02, 2018
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K182596.
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
K182857 · Philips Ultrasound, Inc. · Nov 2018
Vivid T8, Vivid T9
K181934 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Nov 2018
Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
K182427 · Canon Medical Systems Corporation · Nov 2018
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
K182679 · Canon Medical Systems Corporation · Oct 2018
Vivid E80, Vivid E90, Vivid E95
K181685 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Oct 2018
Xperius Ultrasound System
K182529 · Philips Ultrasound, Inc. · Oct 2018