Cleared Traditional

K082224 - DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC

K082224 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND SYSTEM SARANO, manufactured by Shimadzu Medical Systems. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K082224 · Shimadzu Medical Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
131d
Days
Class 2
Risk

K082224 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Shimadzu Medical Systems (Torrance, US). The FDA issued a Cleared decision on December 15, 2008 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K082224

510(k) Number K082224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date December 15, 2008
Days to Decision 131 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
24d slower than avg
Panel avg: 107d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 414
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K082224.
HUMANSCAN M5S-D ULTRASOUND TRANSDUCER
K083824 · Humanscan Company, Ltd. · Feb 2009
NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
K083667 · B-K Medical Aps · Feb 2009
FLYING DIAGNOSTIC ULTRASOUND SYSTEM
K083877 · Neusoft Medical Systems Co., Ltd. · Jan 2009
PRAGER SHELL
K082893 · Esi, Inc. · Dec 2008
UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
K081919 · Fukuda Denshi Co., Ltd. · Sep 2008
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
K081802 · Philips Ultrasound, Inc. · Jul 2008
K082224 · DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
Download PDF FDA Summary Shimadzu Medical Syst…