Cleared Traditional

K940108 - DIAGNOSTIC ULTRASOUND IMAGING CATHETER

K940108 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND IMAGING CATHETER, manufactured by Boston Scientific Corp. 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.

K940108 · Boston Scientific Corp · Radiology device
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Dec 1994
Decision
331d
Days
Class 2
Risk

K940108 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND IMAGING CATHETER. 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 December 7, 1994 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K940108

510(k) Number K940108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date December 07, 1994
Days to Decision 331 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
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 205
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K940108.
V5M
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UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.
K925486 · Aloka Co., Ltd. · Feb 1993