Cleared Traditional

Kelowna GYN and Crook Prostate Templates

K232949 · Varian Medical Systems, Inc. · Radiology
Feb 2024
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K232949 is an FDA 510(k) clearance for the Kelowna GYN and Crook Prostate Templates, 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 February 1, 2024, 134 days after receiving the submission on September 20, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5700.

Submission Details

510(k) Number K232949 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2023
Decision Date February 01, 2024
Days to Decision 134 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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