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

Block, Beam-Shaping, Radiation Therapy

21 CFR 892.5710 / Radiology
FDA source (opens on fda.gov)

IXI is the FDA product code for Block, Beam-Shaping, Radiation Therapy, a class II device type, regulated under 21 CFR 892.5710. As of , FDA records hold 51 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
IXI
Device name
Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
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
Yes
Ingested clearances
51
Ingested recalls
6

Clearances, product code IXI

By decision year
51 clearances under product code IXI with a decision year between 1979 and 2026, 1995 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code IXI by decision year
YearClearances
19791
19841
19851
19861
19881
19892
19901
19911
19942
19953
19962
19973
19983
19991
20003
20012
20022
20032
20042
20063
20072
20093
20112
20121
20133
20222
20261

Applicants with the most clearances

Product code IXI
Applicants holding the most 510(k) clearances under product code IXI
ApplicantClearances
.Decimal, Inc.6
Siemens Medical Solutions USA, Inc.5
Medtec LLC4
Aktina Medical Physics Corp.2
Elekta Limited2
Cura Medical Technologies, LLC2
Huestis Machine Corp.2
Mrc Systems GmbH2
3D Line USA, Inc.1
3D Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code