← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LHN — System, Radiation Therapy, Charged-Particle, Medical

DEVICE CLASS
Class II
REGULATION
21 CFR 892.5050
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K260174Hitachi High-Tech Corp. · 510k2026-06-11
K252815Varian Medical Systems, Inc. · 510k2026-04-23
K253406Mevion Medical Systems, Inc. · 510k2026-03-25
K250986Mevion Medical Systems, Inc. · 510k2025-09-12
K243900Empnia, Inc. · 510k2025-06-27
K242418P-Cure, Ltd. · 510k2025-05-12

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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