Cleared Traditional

Gating Reflector Block

K242874 · Varian Medical Systems, Inc. · Radiology
Nov 2024
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K242874 is an FDA 510(k) clearance for the Gating Reflector Block, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on November 21, 2024, 59 days after receiving the submission on September 23, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K242874 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2024
Decision Date November 21, 2024
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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