Cleared Traditional

KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT

K970738 · Jamieson Film Co. · Radiology
May 1997
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K970738 is an FDA 510(k) clearance for the KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Jamieson Film Co. (Rochester, US). The FDA issued a Cleared decision on May 7, 1997, 68 days after receiving the submission on February 28, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K970738 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 1997
Decision Date May 07, 1997
Days to Decision 68 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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

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