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

System, X-Ray, Fluoroscopic, Non-Image-Intensified

21 CFR 892.1660 / Radiology
FDA source (opens on fda.gov)

JAB is the FDA product code for System, X-Ray, Fluoroscopic, Non-Image-Intensified, a class II device type, regulated under 21 CFR 892.1660. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JAB
Device name
System, X-Ray, Fluoroscopic, Non-Image-Intensified
Regulation
21 CFR 892.1660
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
2
Ingested recalls
0

Clearances, product code JAB

By decision year
2 clearances under product code JAB with a decision year between 1981 and 1997, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JAB by decision year
YearClearances
19811
19971

Applicants with the most clearances

Product code JAB
Applicants holding the most 510(k) clearances under product code JAB
ApplicantClearances
General Robotic Devices, Inc.1
Kontron Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code