Cleared Traditional

Mould Probe MR Safe

K241764 · Varian Medical Systems, Inc. · Radiology
Jan 2025
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K241764 is an FDA 510(k) clearance for the Mould Probe MR Safe, a System, Applicator, Radionuclide, Remote-controlled (Class II — Special Controls, product code JAQ), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on January 10, 2025, 204 days after receiving the submission on June 20, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K241764 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2024
Decision Date January 10, 2025
Days to Decision 204 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAQ — System, Applicator, Radionuclide, Remote-controlled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5700

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