Product code JAB— Radiology

IMAGING JET SYSTEM

Classification name
System, X-Ray, Fluoroscopic, Non-Image-Intensified
Device class
Class 2
Regulation
21 CFR 892.1660
Advisory panel
Radiology
Total cleared
2
First cleared
Most recent

Market context for product code JAB

FDA has cleared 2 devices under product code JAB between 1981 and 1997, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code JAB

Recent clearances under product code JAB

Data sourced from openFDA. This site is unofficial and independent of the FDA.