Cleared Traditional

K863269 - SONOLAYER - V

K863269 is an FDA 510(k) clearance for SONOLAYER - V, manufactured by Toshiba Medical Systems. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 331-day FDA review.

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

FDA 510(k) Submission Details - K863269

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
Combination Product No
PCCP Authorized No
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.

ITX Device Classification - Class 2, Special Controls

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 204
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K863269.
EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX
K870899 · Biosound, Inc. · Dec 1987
ADMS TRANSRECTAL 7.5 MHZ PROBE
K870967 · Diasonics, Inc. · Sep 1987
3.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CW
K871432 · Advanced Technology Laboratories, Inc. · Aug 1987
7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE
K870748 · Philips Ultrasound, Inc. · Apr 1987
TRT TRANS-RECTAL TRANSDUCER
K870038 · Advanced Technology Laboratories, Inc. · Mar 1987
7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12
K863708 · Siemens Medical Solutions USA, Inc. · Mar 1987