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

System, Radiation Therapy, Charged-Particle, Medical

21 CFR 892.5050 / Radiology
FDA source (opens on fda.gov)

LHN is the FDA product code for System, Radiation Therapy, Charged-Particle, Medical, a class II device type, regulated under 21 CFR 892.5050. As of , FDA records hold 92 510(k) clearances under this code, the most recent dated , and 58 recalls.

Classification record

Product code
LHN
Device name
System, Radiation Therapy, Charged-Particle, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
93
Ingested recalls
58

Clearances, product code LHN

By decision year
93 clearances under product code LHN with a decision year between 1985 and 2026, 2006 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code LHN by decision year
YearClearances
19853
19861
19891
19961
19972
19986
19993
20002
20012
20031
20042
20069
20072
20083
20095
20104
20111
20123
20133
20144
20153
20167
20174
20183
20192
20204
20222
20232
20241
20253
20264

Applicants with the most clearances

Product code LHN
Applicants holding the most 510(k) clearances under product code LHN
ApplicantClearances
Ion Beam Applications S.A.13
Varian Medical Systems, Inc.9
Hitachi, Ltd.4
Hitachi, Ltd., Health Care Company4
Mevion Medical Systems, Inc.4
Anzai Medical Co, Ltd.3
Brainlab, Inc.3
Medcom GmbH3
Sicel Technologies, Inc.3
Calypso Medical Technologies, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order