JAD

System, Therapeutic, X-Ray

Product code
JAD
Device name
System, Therapeutic, X-Ray
Device class
Class 2
21 CFR
21 CFR 892.5900
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
53 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-12-03.

NumberDecision dateApplicantDevice nameSummary
K2506922025-12-03Voxel Ray Solutions, LLCGentleBeam (GB1000)FDA
K2411742025-01-10Carl Zeiss Meditec, AGINTRABEAM (700); And accessories (INTRABEAM SMART St…PDF

1 summaries are archived here for direct download.

Official FDA classification page: JAD
Classification and pathway per current FDA publications. Data from openFDA (CC0).