Cleared Traditional

K844128 - EUB-40

K844128 is an FDA 510(k) clearance for EUB-40, manufactured by Hitachi Medical Corp. of America. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K844128 · Hitachi Medical Corp. of America · Radiology device
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Feb 1985
Decision
125d
Days
Class 2
Risk

K844128 is an FDA 510(k) clearance for the EUB-40. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Hitachi Medical Corp. of America (Tarrytown, US). The FDA issued a Cleared decision on February 25, 1985 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - 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

FDA 510(k) Submission Details - K844128

510(k) Number K844128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date February 25, 1985
Days to Decision 125 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
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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 - JAF Monitor, Ultrasonic, Nonfetal

All 26
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K844128.
SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
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KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
K851149 · Keymed, Inc. · Nov 1985
3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802
K852572 · Siemens Medical Solutions USA, Inc. · Sep 1985
HEMACOUNT WRIGHT GIEMSA STAIN PACK
K822602 · Accra Laboratories, Inc. · Sep 1982
VASCULAB BI-DIRECTIONAL DOPPLER, #D10
K800768 · Medasonics, Inc. · Jul 1980