510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163500Substantially Equivalent

IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)

Ion Beam Applications S.A., Louvain-La-Neuve, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163500 is the FDA 510(k) clearance record for IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class), a class II device, cleared for Ion Beam Applications S.A. on under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical). FDA records list 13 510(k) clearances for Ion Beam Applications S.A., from to . As of , FDA records show 11 recalls naming K163500.

Clearance record

Decision date
Received
(247 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
Ion Beam Applications S.A. Chemin Du Cyclotron, 3, Louvain-La-Neuve, BE
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