Cleared Traditional

CRONEX RADIATION THERAPY VERIFICATION CASSETTE

K953725 · E.I. Dupont DE Nemours & Co., Inc. · Radiology
Sep 1995
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K953725 is an FDA 510(k) clearance for the CRONEX RADIATION THERAPY VERIFICATION CASSETTE, a Cassette, Radiographic Film (Class II — Special Controls, product code IXA), submitted by E.I. Dupont DE Nemours & Co., Inc. (Newark, US). The FDA issued a Cleared decision on September 6, 1995, 27 days after receiving the submission on August 10, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1850.

Submission Details

510(k) Number K953725 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1995
Decision Date September 06, 1995
Days to Decision 27 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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