Cleared Special

KODAK CARESTREAM PACS

K053347 · Eastman Kodak Company · Radiology
Jan 2006
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K053347 is an FDA 510(k) clearance for the KODAK CARESTREAM PACS, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on January 4, 2006, 33 days after receiving the submission on December 2, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K053347 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2005
Decision Date January 04, 2006
Days to Decision 33 days
Submission Type Special
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