Cleared Traditional

IsoSphere

K242818 · Isoaid, LLC · Radiology
Jul 2025
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K242818 is an FDA 510(k) clearance for the IsoSphere, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Isoaid, LLC (Port Richey, US). The FDA issued a Cleared decision on July 15, 2025, 300 days after receiving the submission on September 18, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number K242818 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2024
Decision Date July 15, 2025
Days to Decision 300 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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

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