← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

IYE — Accelerator, Linear, 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
22
510(K)/PMA CLEARANCES
510k: 22
0
RECALL ENTRIES

Recent clearances

K252937Dosisoft SA · 510k2026-06-12
K253004Lap GmbH Laser Applikationen · 510k2026-06-04
K260792Stabilix, LLC · 510k2026-05-08
K252258Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · 510k2026-04-15
K253962Radformation, Inc. · 510k2026-04-03
K253012Vision Rt, Ltd. · 510k2026-03-18
K252977Varian Medical Systems, Inc. · 510k2026-01-21
K252188Elekta Solutions AB · 510k2026-01-15

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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