510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872369Substantially Equivalent

Loma Linda Univ. Proton Beam Therapy System

Loma Linda University Medical Center, Loma Linda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872369 is the FDA 510(k) clearance record for LOMA LINDA UNIV. PROTON BEAM THERAPY SYSTEM, a class II device, cleared for Loma Linda University Medical Center on under FDA product code IWM (Synchrotron, Medical). FDA records list one 510(k) clearance for Loma Linda University Medical Center. As of , FDA records show no recalls naming K872369.

Clearance record

Decision date
Received
(248 days to decision)
Product code
IWM Synchrotron, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Loma Linda University Medical Center 11234 Anderson St., Loma Linda CA
Third party review
No

Clearances, product code IWM

Trailing 12 months

FDA records hold no clearances under product code IWM in the trailing twelve months.

FDA records show no clearances under product code IWM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260