Cleared Traditional

K983879 - ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM

K983879 is an FDA 510(k) clearance for ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM, manufactured by Aloka Co., Ltd.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K983879 · Aloka Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
140d
Days
Class 2
Risk

K983879 is an FDA 510(k) clearance for the ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Aloka Co., Ltd. (Wallingford, US). The FDA issued a Cleared decision on March 22, 1999 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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

FDA 510(k) Submission Details - K983879

510(k) Number K983879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1998
Decision Date March 22, 1999
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 655
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K983879.
LIFE IMAGING SYSTEMS, MODEL L3DI
K990560 · Life Imaging Systems, Inc. · May 1999
CTS-310(B)
K984161 · Shantou Institute of Ultrasonic Instuments · May 1999
DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION
K990248 · Dicomit Imaging Systems Corp. · Apr 1999
CORTEX DERMASCAN C ULTRASONIC SYSTEM
K983945 · Cortex Technology Aps · Mar 1999
ACCU GUIDE
K984382 · Tayman Medical, Inc. · Mar 1999
SSA-320A JUST VISION 200/ SSA-325A JUST VISION
K990490 · Toshiba America Medical Systems, In.C · Mar 1999