Device type
Accelerator, Linear, Medical
Product code IYE · Class II · 21 CFR 892.5050 · Radiology
Recent 510(k)s
Sep 16, 2026
K261865
AerFrame™ Alignment Laser Box (LBV2)
Stabilix, LLC
- IYE
- Class II
Aug 31, 2026
K261718
EZFluence (RADEZ V2)
Radformation, Inc.
- IYE
- Class II
Aug 26, 2026
K260733
MRIA Radiation Therapy Information System (MRIA)
Manteia Technologies Co., Ltd.
- IYE
- Class II
Recent recalls
Sep 23, 2026
Z-3174-2026
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
PTW FREIBURG
- IYE
- Class II
- Ongoing