← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
JAA — System, X-Ray, Fluoroscopic, Image-Intensified
DEVICE CLASS
Class II
REGULATION
21 CFR 892.1650
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES
Recent clearances
K253103Varex Imaging Corporation · 510k2026-05-29
K251650Imaging Engineering, LLC · 510k2025-09-16
K242488Omega Medical Imaging, LLC · 510k2025-01-06
K242948Nrt X-Ray A/S · 510k2024-12-23
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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