Cleared Traditional

K970049 - BSC

K970049 is an FDA 510(k) clearance for BSC, 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 165-day FDA review.

K970049 · Cardiovascular Imaging Systems, Inc. · Radiology device
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Jun 1997
Decision
165d
Days
Class 2
Risk

K970049 is an FDA 510(k) clearance for the BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH .... 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 June 20, 1997 after a review of 165 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 - K970049

510(k) Number K970049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1997
Decision Date June 20, 1997
Days to Decision 165 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
58d slower than avg
Panel avg: 107d · This submission: 165d
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 238
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K970049.
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BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER
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GENERAL PURPOSE TRANDUCER COVER
K970513 · CIVCO Medical Instruments Co., Inc. · Jun 1997
DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE
K970514 · CIVCO Medical Instruments Co., Inc. · Jun 1997
GENERAL PURPOSE LATEX TRANSDUCER COVERS
K970515 · CIVCO Medical Instruments Co., Inc. · Jun 1997