Cleared Traditional

K862164 - EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER

K862164 is an FDA 510(k) clearance for EUP-012I, manufactured by Hitachi Medical Corp. of America. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K862164 · Hitachi Medical Corp. of America · Radiology device
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Nov 1986
Decision
151d
Days
Class 2
Risk

K862164 is an FDA 510(k) clearance for the EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER. 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 November 4, 1986 after a review of 151 days - an extended review 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: 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 - K862164

510(k) Number K862164 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 06, 1986
Decision Date November 04, 1986
Days to Decision 151 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
44d slower than avg
Panel avg: 107d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

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 682
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