510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K191521Substantially Equivalent

Radiance 330 Proton Beam Therapy System

Protom International Holding Corporation, Wakefield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191521 is the FDA 510(k) clearance record for Radiance 330 Proton Beam Therapy System, a class II device, cleared for Protom International Holding Corporation on under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical). FDA records list one 510(k) clearance for Protom International Holding Corporation. As of , FDA records show no recalls naming K191521.

Clearance record

Decision date
Received
(112 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
Protom International Holding Corporation 500 Edgewater Pl. Suite 522, Wakefield MA
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