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

System, Planning, Radiation Therapy Treatment

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

MUJ is the FDA product code for System, Planning, Radiation Therapy Treatment, a class II device type, regulated under 21 CFR 892.5050. As of , FDA records hold 257 510(k) clearances under this code, the most recent dated , and 267 recalls.

Classification record

Product code
MUJ
Device name
System, Planning, Radiation Therapy Treatment
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
257
Ingested recalls
267

Clearances, product code MUJ

By decision year
257 clearances under product code MUJ with a decision year between 1995 and 2026, 2009 the highest year at 16.
Show the numbers
510(k) clearances under FDA product code MUJ by decision year
YearClearances
19951
19985
199910
200014
20018
200211
20038
20048
20056
20069
20074
20089
200916
201011
20119
20128
20135
20149
201513
20165
20177
20187
20199
20209
202111
20228
202310
20249
202510
20268

Applicants with the most clearances

Product code MUJ
Applicants holding the most 510(k) clearances under product code MUJ
ApplicantClearances
Varian Medical Systems, Inc.34
RaySearch Laboratories AB (publ)22
Accuray Incorporated13
Elekta Limited13
Nucletron BV13
Siemens Medical Solutions USA, Inc.13
Brainlab, Inc.11
.Decimal, Inc.7
Philips North America LLC7
Prowess, Inc.6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order