Cleared Traditional

K905294 - EUB-315

K905294 is the FDA 510(k) clearance for EUB-315 by Hitachi Medical Corp. of America. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K905294 · Hitachi Medical Corp. of America · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
90d
Days
Class 2
Risk

K905294 is an FDA 510(k) clearance for the EUB-315. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Hitachi Medical Corp. of America (Tarrytown, US). The FDA issued a Cleared decision on February 25, 1991 after a review of 90 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 Corp. of America devices

Submission Details

510(k) Number K905294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1990
Decision Date February 25, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
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 423
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K905294.
ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM
K920374 · Ge Medical Systems Information Technologies · Apr 1992
COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR
K910956 · Storz Instrument Co. · Sep 1991
ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)
K903603 · Advanced Technology Laboratories, Inc. · Feb 1991
EUB-565 DIAGNOSTIC ULTRASOUND DEVICE
K896100 · Hitachi Medical Corp. of America · Jan 1991
NIDEK US-2000
K903326 · Nidek, Inc. · Nov 1990
BIOPSY NEEDLE TRANSPONDER SYSTEM
K902214 · Advanced Technology Laboratories, Inc. · Nov 1990