Hearttrace Left Ventricular Analysis Software

FDA 510(k) K933073 · Heartware Intl. Corp.

Substantially Equivalent

510(k) numberK933073

Submission

Device name
Hearttrace Left Ventricular Analysis Software
Applicant
Heartware Intl. Corp.
North Attleboro, MA, US
Received
June 23, 1993
Decision date
October 7, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IZI – System, X-Ray, Angiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1600
Specialty
Radiology

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More from Surgvision GmbH

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Questions and answers

When was Hearttrace Left Ventricular Analysis Software cleared by the FDA?

Hearttrace Left Ventricular Analysis Software (K933073) received a 510(k) decision of Substantially Equivalent on October 7, 1993, 106 days after the submission was received.

What is the product code of K933073?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.