Cleared Traditional

K913890 - SONICATH(TM) 3.5 F

K913890 is an FDA 510(k) clearance for SONICATH(TM) 3.5 F, 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 438-day FDA review.

K913890 · Boston Scientific Corp · Radiology device
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Nov 1992
Decision
438d
Days
Class 2
Risk

K913890 is an FDA 510(k) clearance for the SONICATH(TM) 3.5 F, 20 MHZ. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on November 9, 1992 after a review of 438 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K913890

510(k) Number K913890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1991
Decision Date November 09, 1992
Days to Decision 438 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
331d slower than avg
Panel avg: 107d · This submission: 438d
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 K913890.
ACUSON V714 TRANSDUCER
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ACUSON V714OR TRANSDUCER
K921341 · Acuson Corp. · Nov 1992
UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35
K922549 · Aloka Co., Ltd. · Sep 1992
CPA/3.5 MHZ PROBE
K911435 · Diasonics, Inc. · Sep 1992
ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP
K902515 · Acuson Corp. · Sep 1992