Cleared Traditional

SONOLAYER - V, SSA-100A. (K863269) - FDA 510(k) Clearance

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

K863269 · Toshiba Medical Systems · Radiology device
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Jul 1987
Decision
331d
Days
Class 2
Risk

K863269 is an FDA 510(k) clearance for the SONOLAYER - V, SSA-100A.. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on July 22, 1987 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Toshiba Medical Systems devices

Submission Details

510(k) Number K863269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date July 22, 1987
Days to Decision 331 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 107d · This submission: 331d
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 94
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K863269.
RADIUS AND SONOCHROME
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RADIUS CF
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7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12
K863708 · Siemens Medical Solutions USA, Inc. · Mar 1987
SERIES 620 RECTAL PROBE COVER
K864222 · General Electric Co. · Mar 1987
INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER
K855247 · Codman & Shurtleff, Inc. · Feb 1987