← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MUJ — System, Planning, Radiation Therapy Treatment

DEVICE CLASS
Class II
REGULATION
21 CFR 892.5050
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
23
510(K)/PMA CLEARANCES
510k: 23
0
RECALL ENTRIES

Recent clearances

K260750Varian Medical Systems, Inc. · 510k2026-07-08
K253050Informai · 510k2026-06-18
K260207Philips Medical Systems Nederland B.V. · 510k2026-05-27
K252784Anatomical Geometry S.L. · 510k2026-05-22
K253078Seetreat Pty, Ltd. · 510k2026-05-14
K252304Varian Medical Systems, Inc. · 510k2026-03-18
K252002Elekta Solutions AB · 510k2026-02-19
K260308Adaptiiv Medical Technologies, Inc. · 510k2026-02-19

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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