Cleared Traditional

K890532 - EUP-C321 5.0MHZ CONVEX TYPE PROBE

K890532 is an FDA 510(k) clearance for EUP-C321 5.0MHZ CONVEX TYPE PROBE, manufactured by Hitachi Medical Corp. of America. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 435-day FDA review.

K890532 · Hitachi Medical Corp. of America · Radiology device
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Apr 1990
Decision
435d
Days
Class 2
Risk

K890532 is an FDA 510(k) clearance for the EUP-C321 5.0MHZ CONVEX TYPE PROBE. 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 April 13, 1990 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Hitachi Medical Corp. of America devices

FDA 510(k) Submission Details - K890532

510(k) Number K890532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1989
Decision Date April 13, 1990
Days to Decision 435 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
328d slower than avg
Panel avg: 107d · This submission: 435d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

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 205
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K890532.
ADDITIONAL TRANSDUCERS FOR USE W/SDL 300
K897073 · Shimadzu Corp. · Aug 1990
FUJINON EDU SYSTEM
K894763 · Fujinon, Inc. · May 1990
EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE
K890531 · Hitachi Medical Corp. of America · Apr 1990
SIEMENS ENDO-P-PROBE
K897098 · Siemens Medical Solutions USA, Inc. · Feb 1990
RADIUS CF
K894547 · General Electric Co. · Nov 1989
EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX
K870899 · Biosound, Inc. · Dec 1987