Cleared Traditional

K933073 - HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE

K933073 is an FDA 510(k) clearance for HEARTTRACE LEFT VENTRICULAR ANALYSIS SO..., manufactured by Heartware Intl. Corp.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K933073 · Heartware Intl. Corp. · Radiology device
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Oct 1993
Decision
106d
Days
Class 2
Risk

K933073 is an FDA 510(k) clearance for the HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Heartware Intl. Corp. (North Attleboro, US). The FDA issued a Cleared decision on October 7, 1993 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 Heartware Intl. Corp. devices

FDA 510(k) Submission Details - K933073

510(k) Number K933073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1993
Decision Date October 07, 1993
Days to Decision 106 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 167
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K933073.
POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE)
K933664 · Siemens Gammasonics, Inc. · Dec 1993
X-RAY ANGIOGRAPHIC SYSTEM
K934496 · Camtronics, Ltd. · Dec 1993
MULTI-VIEW PROCESSOR (MVP)
K931184 · Adac Laboratories · Nov 1993
MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM
K930635 · Siemens Medical Solutions USA, Inc. · Sep 1993
DLX
K926258 · GE Medical Systems · Mar 1993
ANCOR
K924719 · Siemens Medical Solutions USA, Inc. · Dec 1992