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

Couch, Radiation Therapy, Powered

21 CFR 892.5770 / Radiology
FDA source (opens on fda.gov)

JAI is the FDA product code for Couch, Radiation Therapy, Powered, a class II device type, regulated under 21 CFR 892.5770. As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
JAI
Device name
Couch, Radiation Therapy, Powered
Regulation
21 CFR 892.5770
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
32
Ingested recalls
18

Clearances, product code JAI

By decision year
32 clearances under product code JAI with a decision year between 1983 and 2024, 2004 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JAI by decision year
YearClearances
19831
19841
19861
19913
19951
19971
19981
19991
20001
20011
20031
20044
20051
20063
20072
20124
20131
20161
20171
20191
20241

Applicants with the most clearances

Product code JAI
Applicants holding the most 510(k) clearances under product code JAI
ApplicantClearances
3C-Medical Intelligence GmbH3
Nomos Corp.3
Brainlab, Inc.2
Forte Automation Systems, Inc.2
Med-Tec, Inc. D/B/A Civco Medical Solutions2
Medtec LLC2
Siemens Medical Solutions USA, Inc.2
Anholt Technologies Inc.2
Accuray Incorporated1
Aktina Medical Physics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code