Cleared Traditional

DS CASSETTE

K053173 · Konica Minolta Medical & Graphic, Inc. · Radiology
Dec 2005
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K053173 is an FDA 510(k) clearance for the DS CASSETTE, a Cassette, Radiographic Film (Class II — Special Controls, product code IXA), submitted by Konica Minolta Medical & Graphic, Inc. (Mie-Ken, JP). The FDA issued a Cleared decision on December 15, 2005, 31 days after receiving the submission on November 14, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1850.

Submission Details

510(k) Number K053173 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2005
Decision Date December 15, 2005
Days to Decision 31 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXA — Cassette, Radiographic Film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1850

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