Cleared Special

PACS SOFTWARE SOLUTION 2003

K033624 · Canon USA, Inc. · Radiology
Dec 2003
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K033624 is an FDA 510(k) clearance for the PACS SOFTWARE SOLUTION 2003, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Canon USA, Inc. (San Diego, US). The FDA issued a Cleared decision on December 15, 2003, 27 days after receiving the submission on November 18, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K033624 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2003
Decision Date December 15, 2003
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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