Cleared Traditional

ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500 (K896644) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896644 · Shimadzu Corp. · Radiology device
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Aug 1990
Decision
270d
Days
Class 2
Risk

K896644 is an FDA 510(k) clearance for the ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Shimadzu Corp. (Gardena, US). The FDA issued a Cleared decision on August 21, 1990 after a review of 270 days - an extended review cycle.

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 Shimadzu Corp. devices

Submission Details

510(k) Number K896644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1989
Decision Date August 21, 1990
Days to Decision 270 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 107d · This submission: 270d
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 64
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K896644.
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K863708 · Siemens Medical Solutions USA, Inc. · Mar 1987