Cleared Traditional

K912363 - ELECTRONIC ULTRASOUND SCAN MODELS EUP-U...

K912363 is the FDA 510(k) clearance for ELECTRONIC ULTRASOUND SCAN MODELS EUP-U... by Hitachi Medical Corp. of America. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K912363 · Hitachi Medical Corp. of America · Radiology device
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Aug 1991
Decision
90d
Days
Class 2
Risk

K912363 is an FDA 510(k) clearance for the ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Hitachi Medical Corp. of America (Tarrytown, US). The FDA issued a Cleared decision on August 27, 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 892.1570 - 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 Hitachi Medical Corp. of America devices

Submission Details

510(k) Number K912363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1991
Decision Date August 27, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
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 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 202
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K912363.
PSF-50ET
K910850 · Toshiba America Medical Systems, In.C · Jan 1992
BIOPSY ACCESSORIES FOR ULTRASOUND PROBES
K912088 · Biosound, Inc. · Dec 1991
ACUSON V510 TRANSDUCER
K911767 · Acuson Corp. · Oct 1991
CW DOPPLER/4.5 MHZ
K903984 · Diasonics, Inc. · Jun 1991
OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12
K900880 · Olympus Corp. · Apr 1991
UST-974-5 CONVEX TRANSDUCER
K911309 · Ge Medical Systems Information Technologies · Apr 1991