Virtual Cone (1.0)— 510(k) K260750

Substantially Equivalent

Varian Medical Systems, Inc.

FDA 510(k) clearance K260750 for Virtual Cone (1.0), Substantially Equivalent on 2026-07-08. Applicant: Varian Medical Systems, Inc.. Device class: 2.

Summary

Varian Medical Systems' Virtual Cone (1.0) is filed under MUJ, radiation therapy treatment planning systems. The record gives a version number but doesn't describe what the software does beyond that code name.

Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Varian filed from Palo Alto, California. The decision came 124 calendar days after FDA received it (March 6 to July 8, 2026).

Clearance details

Applicant
Varian Medical Systems, Inc.
Product code
Product code MUJ
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Palo Alto, CA, US
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