Cleared Abbreviated

SHIMADZU COLLIMATOR R-20J

K042840 · Shimadzu Corp. · Radiology
Dec 2004
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K042840 is an FDA 510(k) clearance for the SHIMADZU COLLIMATOR R-20J, a Collimator, Manual, Radiographic (Class II — Special Controls, product code IZX), submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on December 3, 2004, 50 days after receiving the submission on October 14, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K042840 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2004
Decision Date December 03, 2004
Days to Decision 50 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZX — Collimator, Manual, Radiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610