Cleared Traditional

K941652 - ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SY...

K941652 is the FDA 510(k) clearance for ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SY... by Aloka Co., Ltd.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K941652 · Aloka Co., Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Oct 1994
Decision
199d
Days
Class 2
Risk

K941652 is an FDA 510(k) clearance for the ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Aloka Co., Ltd. (Wallingford, US). The FDA issued a Cleared decision on October 21, 1994 after a review of 199 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 K941652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1994
Decision Date October 21, 1994
Days to Decision 199 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
92d slower than avg
Panel avg: 107d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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