Hearttrack Quantitative Coronary Angiography Softw

FDA 510(k) K933058 · Heartware Intl. Corp.

Substantially Equivalent

510(k) numberK933058

Submission

Device name
Hearttrack Quantitative Coronary Angiography Softw
Applicant
Heartware Intl. Corp.
North Attleboro, MA, US
Received
June 22, 1993
Decision date
September 28, 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

Other 510(k)s with product code IZI

510(k)DeviceApplicantDecision
K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional Stryker Endoscopy05/28/2026SE
K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformIZI · Traditional Surgimage Corporation05/13/2026SE
K243645IC-Flow™ Imaging System 2.0IZI · Traditional Diagnostic Green GmbH09/22/2025SE
K243077Affirm 800IZI · Traditional Digital Surgery Systems, Inc. (D.B.A True…06/27/2025SE
K231986Modus IRIZI · Traditional Synaptive Medical, Inc.03/25/2024SE
K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)IZI · Traditional Surgvision GmbH03/20/2024SE
K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZI · Traditional Carl Zeiss Meditec, Inc.06/20/2023SE
K230727SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional Novadaq Technologies Ulc (A Part of Stryker)06/05/2023SE
K222240Explorer Air® IIIZI · Traditional Surgvision GmbH02/28/2023SE
K214097Explorer Air IIIZI · Traditional Surgvision GmbH02/25/2022SE

More from Surgvision GmbH

510(k)DeviceDecision
K932410Heartview(R) Coronary Angiograph Diagram/Report SyIZI · Traditional 12/13/1993SE
K933073Hearttrace Left Ventricular Analysis SoftwareIZI · Traditional 10/07/1993SE
K893094HB 1000, Brugada Electrophysiology SystemJOQ · Traditional 10/02/1989SE

Questions and answers

When was Hearttrack Quantitative Coronary Angiography Softw cleared by the FDA?

Hearttrack Quantitative Coronary Angiography Softw (K933058) received a 510(k) decision of Substantially Equivalent on September 28, 1993, 98 days after the submission was received.

What is the product code of K933058?

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