Cleared Traditional

K873674 - SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER

K873674 is an FDA 510(k) clearance for SDU-700 PHASED ARRAY SECTOR AND LINEAR ..., manufactured by Shimadzu Corp.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K873674 · Shimadzu Corp. · Cardiovascular device
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Oct 1988
Decision
392d
Days
Class 2
Risk

K873674 is an FDA 510(k) clearance for the SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Shimadzu Corp. (Kyoto City 604 Japan, JP). The FDA issued a Cleared decision on October 7, 1988 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - the FDA cardiovascular device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shimadzu Corp. devices

FDA 510(k) Submission Details - K873674

510(k) Number K873674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1987
Decision Date October 07, 1988
Days to Decision 392 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
267d slower than avg
Panel avg: 125d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOP Transducer, Ultrasonic

All 54
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K873674.
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