Cleared Traditional

MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER

K982937 · Victoreen, Inc. · Radiology
Nov 1998
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K982937 is an FDA 510(k) clearance for the MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER, a System, Radiation Therapy, Charged-particle, Medical (Class II — Special Controls, product code LHN), submitted by Victoreen, Inc. (Solon, US). The FDA issued a Cleared decision on November 19, 1998, 90 days after receiving the submission on August 21, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K982937 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1998
Decision Date November 19, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LHN — System, Radiation Therapy, Charged-particle, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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