Cleared Traditional

READI-LOAD SYSTEM, MODEL PSS 1820RL

K022389 · Worldwide Medical Technologies, LLC · Radiology
May 2003
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K022389 is an FDA 510(k) clearance for the READI-LOAD SYSTEM, MODEL PSS 1820RL, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on May 6, 2003, 287 days after receiving the submission on July 23, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number K022389 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2002
Decision Date May 06, 2003
Days to Decision 287 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code KXK — Source, Brachytherapy, Radionuclide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5730

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