Cleared Abbreviated

DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE

K050925 · Shimadzu Corp. · Radiology
Jun 2005
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K050925 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on June 1, 2005, 49 days after receiving the submission on April 13, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K050925 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2005
Decision Date June 01, 2005
Days to Decision 49 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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