Cinenet Cardiac Image Network

Q: What is the product code of K924708?

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

FDA 510(k) K924708 · Sony Medical Systems

Substantially Equivalent

510(k) numberK924708

Submission

Device name: Cinenet Cardiac Image Network
Applicant: Sony Medical Systems
Attleboro, MA, US
Received: September 18, 1992
Decision date: December 30, 1992
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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K231075	Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZI · Traditional	Carl Zeiss Meditec, Inc.	06/20/2023SE
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K222240	Explorer Air® IIIZI · Traditional	Surgvision GmbH	02/28/2023SE
K214097	Explorer Air IIIZI · Traditional	Surgvision GmbH	02/25/2022SE

More from Surgvision GmbH

510(k)	Device	Decision
K024188	UP-DF500 Filmstation Digital Film ImagerLMC · Traditional	02/04/2003SE
K970999	Sony PGM-100P1MD Trinitron Color Graphic MonitorJAK · Traditional	05/20/1997SE
K961680	Sony DKR-700 Digital Still RecorderLMB · Traditional	07/03/1996SE
K931170	Sony Cardiac Analysis and Review Station (Cars)IZI · Traditional	06/14/1993SE
K921275	Sony Laser Videodisc Recording SystemLMB · Traditional	06/10/1992SE

Questions and answers

When was Cinenet Cardiac Image Network cleared by the FDA?

Cinenet Cardiac Image Network (K924708) received a 510(k) decision of Substantially Equivalent on December 30, 1992, 103 days after the submission was received.

What is the product code of K924708?

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