Cleared Traditional

K071287 - ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO

K071287 is an FDA 510(k) clearance for ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRAS..., 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 246-day FDA review.

K071287 · Shimadzu Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
246d
Days
Class 2
Risk

K071287 is an FDA 510(k) clearance for the ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO. 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 January 9, 2008 after a review of 246 days - an extended review cycle.

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.

View all Shimadzu Medical Systems devices

FDA 510(k) Submission Details - K071287

510(k) Number K071287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2007
Decision Date January 09, 2008
Days to Decision 246 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
139d slower than avg
Panel avg: 107d · This submission: 246d
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 332
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K071287.
ATLANTIS 018 PERIPHERAL IMAGING CATHETER
K073623 · Boston Scientific Corp · Mar 2008
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
K080272 · Boston Scientific Corp · Mar 2008
CLEARSCAN
K080119 · Esi, Inc. · Feb 2008
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
K071289 · Shimadzu Medical Systems · Jan 2008
ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
K071291 · Shimadzu Medical Systems · Jan 2008
ACUSON S2000 ULTRASOUND SYSTEM
K072786 · Siemens Medical Solutions USA, Inc. · Nov 2007