Cleared Traditional

IDENTIFY (5.0)

K252919 · Varian Medical Systems, Inc. · Radiology
Dec 2025
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K252919 is an FDA 510(k) clearance for the IDENTIFY (5.0), 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 December 16, 2025, 95 days after receiving the submission on September 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K252919 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2025
Decision Date December 16, 2025
Days to Decision 95 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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