Kodak Digital Science Cardiac Digital Acquisition Unit

FDA 510(k) K970738 · Jamieson Film Co.

Substantially Equivalent

510(k) numberK970738

Submission

Device name
Kodak Digital Science Cardiac Digital Acquisition Unit
Applicant
Jamieson Film Co.
Rochester, NY, US
Received
February 28, 1997
Decision date
May 7, 1997
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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Questions and answers

When was Kodak Digital Science Cardiac Digital Acquisition Unit cleared by the FDA?

Kodak Digital Science Cardiac Digital Acquisition Unit (K970738) received a 510(k) decision of Substantially Equivalent on May 7, 1997, 68 days after the submission was received.

What is the product code of K970738?

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