510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
JADClass II

System, Therapeutic, X-Ray

21 CFR 892.5900 / Radiology
FDA source (opens on fda.gov)

JAD is the FDA product code for System, Therapeutic, X-Ray, a class II device type, regulated under 21 CFR 892.5900. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
JAD
Device name
System, Therapeutic, X-Ray
Regulation
21 CFR 892.5900
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
53
Ingested recalls
12

Clearances, product code JAD

By decision year
53 clearances under product code JAD with a decision year between 1978 and 2025, 2013 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JAD by decision year
YearClearances
19784
19811
19821
19831
19851
19862
19871
19882
19891
19902
19932
19961
19974
19981
19991
20052
20071
20082
20093
20111
20122
20135
20141
20151
20162
20171
20181
20192
20221
20231
20252

Applicants with the most clearances

Product code JAD
Applicants holding the most 510(k) clearances under product code JAD
ApplicantClearances
Sensus Healthcare6
Carl Zeiss Meditec Inc4
Carl Zeiss Surgical GmbH3
iCAD, Inc.3
Xoft, Inc.3
Philips North America LLC2
Emi Therapy Systems, Inc.2
Nucletron BV2
Pantak, Inc.2
Photoelectron Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order