Cleared Traditional

K943637 - SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM

K943637 is the FDA 510(k) clearance for SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM by Aloka Co., Ltd.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K943637 · Aloka Co., Ltd. · Radiology device
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Dec 1994
Decision
155d
Days
Class 2
Risk

K943637 is an FDA 510(k) clearance for the SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Aloka Co., Ltd. (Wallingford, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 155 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 Aloka Co., Ltd. devices

Submission Details

510(k) Number K943637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1994
Decision Date December 29, 1994
Days to Decision 155 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 107d · This submission: 155d
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 190
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K943637.
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ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS
K921695 · Parker Laboratories, Inc. · Feb 1995
DIAGNOSTIC ULTRASOUND IMAGING CATHETER
K940108 · Boston Scientific Corp · Dec 1994
MODIFICATION OF ACUSON V510B TRANSDUCER
K933663 · Acuson Corp. · Jan 1994
ACUSON V714 TRANSDUCER
K920882 · Acuson Corp. · Mar 1993