Cleared Abbreviated

SHIMADZU COLLIMATOR R-20J

K101036 · Shimadzu Corp. · Radiology
Aug 2010
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K101036 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 August 26, 2010, 134 days after receiving the submission on April 14, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K101036 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2010
Decision Date August 26, 2010
Days to Decision 134 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