510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252815Substantially Equivalent

ProBeam 360 Proton Therapy System v3.0

Varian Medical Systems, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252815 is the FDA 510(k) clearance record for ProBeam 360 Proton Therapy System v3.0, a class II device, cleared for Varian Medical Systems, Inc. on under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical). FDA records list 238 510(k) clearances for Varian Medical Systems, Inc., from to . As of , FDA records show no recalls naming K252815.

Clearance record

Decision date
Received
(231 days to decision)
Product code
LHN System, Radiation Therapy, Charged-Particle, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Varian Medical Systems, Inc. 3100 Hansen Way, Palo Alto CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHN

Trailing 12 months
4 clearances under product code LHN in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260