Cleared Traditional

Identify (4.0)

K242957 · Varian Medical Systems, Inc. · Radiology
Feb 2025
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K242957 is an FDA 510(k) clearance for the Identify (4.0), a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 7, 2025, 135 days after receiving the submission on September 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K242957 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2024
Decision Date February 07, 2025
Days to Decision 135 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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