Cleared Traditional

K902245 - SONICATH(TM) 9F

K902245 is the FDA 510(k) clearance for SONICATH(TM) 9F by Boston Scientific Corp. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K902245 · Boston Scientific Corp · Radiology device
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Oct 1990
Decision
144d
Days
Class 2
Risk

K902245 is an FDA 510(k) clearance for the SONICATH(TM) 9F, 12 MHZ. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on October 9, 1990 after a review of 144 days - within the typical 510(k) review window.

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. 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 Boston Scientific Corp devices

Submission Details

510(k) Number K902245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1990
Decision Date October 09, 1990
Days to Decision 144 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
37d slower than avg
Panel avg: 107d · This submission: 144d
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 202
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