Cleared Traditional

FUJI FCR IMAGE PROCESSING UNIT IP-U515

K942561 · Fujifilm Medical System U.S.A., Inc. · Radiology
Dec 1994
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K942561 is an FDA 510(k) clearance for the FUJI FCR IMAGE PROCESSING UNIT IP-U515, a System, Imaging, X-ray, Electrostatic (Class II — Special Controls, product code IXK), submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on December 23, 1994, 206 days after receiving the submission on May 31, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1630.

Submission Details

510(k) Number K942561 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1994
Decision Date December 23, 1994
Days to Decision 206 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXK — System, Imaging, X-ray, Electrostatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1630

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