Cleared Traditional

COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A (K963705) - FDA 510(k) Clearance

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

K963705 · Toshiba America Medical Systems, In.C · Radiology device
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Dec 1996
Decision
77d
Days
Class 2
Risk

K963705 is an FDA 510(k) clearance for the COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A. 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 Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on December 2, 1996 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K963705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date December 02, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
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

All 535
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K963705.
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K990339 · Hewlett-Packard Co. · Feb 1999
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING
K980557 · Siemens Medical Solutions USA, Inc. · Apr 1998
SONOS 2000, SONOS 2500 (M2406 A)
K964309 · Hewlett-Packard Co. · Apr 1997
HP SONOS ULTRASOUND IMAGING SYSTEM
K954028 · Hewlett-Packard Co. · Aug 1996
HP SONOS 100CF ULTRASOUND IMAGING SYSTEM
K955327 · Hewlett-Packard Co. · Apr 1996
SIEMENS Q4000
K945072 · Siemens Medical Solutions USA, Inc. · Nov 1995