Cleared Traditional

SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS

K040870 · Shimadzu Corp. · Radiology
May 2004
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K040870 is an FDA 510(k) clearance for the SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on May 17, 2004, 45 days after receiving the submission on April 2, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K040870 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2004
Decision Date May 17, 2004
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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