JAB — System, X-Ray, Fluoroscopic, Non-Image-Intensified Class II

FDA Device Classification

FDA product code JAB covers "System, X-Ray, Fluoroscopic, Non-Image-Intensified", a Class II medical device regulated under 21 CFR 892.1660. Submissions are reviewed by the Radiology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JAB
Device Class
Class II
Regulation Number
892.1660
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K970782general robotic devicesIMAGING JET SYSTEMNovember 13, 1997
K813032kontron instrumentsZIKON 100 DIGITAL X-RAY SYSTEMNovember 24, 1981