Cleared Traditional

KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM

K960043 · Jamieson Film Co. · Radiology
Mar 1996
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K960043 is an FDA 510(k) clearance for the KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Jamieson Film Co. (Rochester, US). The FDA issued a Cleared decision on March 27, 1996, 84 days after receiving the submission on January 3, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K960043 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1996
Decision Date March 27, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050