Cleared Traditional

K011252 - EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER ...

K011252 is the FDA 510(k) clearance for EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER ... by Hitachi Medical Corp.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K011252 · Hitachi Medical Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
36d
Days
Class 2
Risk

K011252 is an FDA 510(k) clearance for the EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Hitachi Medical Corp. (Tarrytown, US). The FDA issued a Cleared decision on May 30, 2001 after a review of 36 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 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 Hitachi Medical Corp. devices

Submission Details

510(k) Number K011252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2001
Decision Date May 30, 2001
Days to Decision 36 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 424
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K011252.
SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
K012253 · Aloka Co., Ltd. · Aug 2001
GE LOGIQ A100 MP, MODEL 2272413
K012560 · General Electric Co. · Aug 2001
CYPRESS SYSTEM
K010950 · Acuson Corp. · Jun 2001
3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
K002807 · Acuson Corp. · Dec 2000
POCKET ULTRASONIC PACHYMETER
K993674 · Quantel Medical · Jul 2000
GE LOGIQ 700
K000516 · Ge Medical Systems, Inc. · Apr 2000