Cleared Traditional

K924126 - EUB-405

K924126 is the FDA 510(k) clearance for EUB-405 by Hitachi Medical Systems America, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K924126 · Hitachi Medical Systems America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
115d
Days
Class 2
Risk

K924126 is an FDA 510(k) clearance for the EUB-405. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on December 10, 1992 after a review of 115 days - within the typical 510(k) review window.

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: 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 Hitachi Medical Systems America, Inc. devices

Submission Details

510(k) Number K924126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1992
Decision Date December 10, 1992
Days to Decision 115 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
8d slower than avg
Panel avg: 107d · This submission: 115d
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 408
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K924126.
FUKUDA DENSHI MODEL UF-4500
K922208 · Fukuda Denshi USA, Inc. · Aug 1993
MATRIX CCM 600
K926009 · Heraeus Kulzer, Inc. · Jul 1993
SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS.
K925646 · Aloka Co., Ltd. · Feb 1993
CONVEX AND LINEAR ARRAY TRANSDUCERS
K923269 · Aloka Co., Ltd. · Dec 1992
ACUSON IMAGE MANAGEMENT SYSTEM
K921670 · Acuson Corp. · Jun 1992
ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM
K920374 · Ge Medical Systems Information Technologies · Apr 1992