Cleared Traditional

KODAK PACS

K060055 · Eastman Kodak Company · Radiology
Feb 2006
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K060055 is an FDA 510(k) clearance for the KODAK 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 February 7, 2006, 29 days after receiving the submission on January 9, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K060055 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2006
Decision Date February 07, 2006
Days to Decision 29 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