Cleared Traditional

K911414 - CVIS INSIGHT IMAGING CATHETERS

K911414 is an FDA 510(k) clearance for CVIS INSIGHT IMAGING CATHETERS, manufactured by Cardiovascular Imaging Systems, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K911414 · Cardiovascular Imaging Systems, Inc. · Radiology device
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Sep 1991
Decision
163d
Days
Class 2
Risk

K911414 is an FDA 510(k) clearance for the CVIS INSIGHT IMAGING CATHETERS. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Cardiovascular Imaging Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 11, 1991 after a review of 163 days - an extended review cycle.

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 Cardiovascular Imaging Systems, Inc. devices

FDA 510(k) Submission Details - K911414

510(k) Number K911414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date September 11, 1991
Days to Decision 163 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
56d slower than avg
Panel avg: 107d · This submission: 163d
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 239
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K911414.
CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND
K912776 · Cardio Metrics, Inc. · Jan 1992
BIOPSY ACCESSORIES FOR ULTRASOUND PROBES
K912088 · Biosound, Inc. · Dec 1991
ACUSON V510 TRANSDUCER
K911767 · Acuson Corp. · Oct 1991
ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3
K912363 · Hitachi Medical Corp. of America · Aug 1991
CW DOPPLER/4.5 MHZ
K903984 · Diasonics, Inc. · Jun 1991
OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12
K900880 · Olympus Corp. · Apr 1991