ClearanceBrief
Panels › Radiology › Product code IYE · Class 2

Accelerator, Linear, Medical

Regulation 892.5050

15510(k)s in 12 months (738 all time)
8recalls in 12 months (563 all time)
542recalls that name a 510(k)
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Top companies in IYE

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.18206
Varian Medical Systems8327
Elekta , Ltd.1977
Varian Medical Systems, Oncology Systems268
Accuray Incorporated1932
Landauer139
Brainlab2217
Varian Assoc., Inc.270
Medtec, Inc.200
Sun Nuclear Corp.191
Decided510(k)Device and applicantCode
Sep 16, 2026K261865AerFrame™ Alignment Laser Box (LBV2)
Stabilix, LLC
IYE
Aug 31, 2026K261718EZFluence (RADEZ V2)
Radformation, Inc.
IYE
Aug 26, 2026K260733MRIA Radiation Therapy Information System (MRIA)
Manteia Technologies Co., Ltd., CN
IYE
Aug 3, 2026K261856Halcyon, Ethos Radiotherapy System (5.0)
Varian Medical Systems, Inc.
IYE
Jun 12, 2026K252937ThinkQA 3
Dosisoft SA, FR
IYE
Jun 4, 2026K253004LUNA 3D
Lap GmbH Laser Applikationen, DE
IYE
May 8, 2026K260792AerFrame Patient Immobilization System (AFPIS)
Stabilix, LLC
IYE
Apr 15, 2026K252258VERIQA RT EPID 3D
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla, DE
IYE
Apr 3, 2026K253962ClearCheck (RADCC V2.7)
Radformation, Inc.
IYE
Mar 18, 2026K253012AlignRT Plus (8.0)
Vision Rt, Ltd., GB
IYE
Jan 21, 2026K252977Halcyon, Ethos Radiotherapy System (5.0)
Varian Medical Systems, Inc.
IYE
Jan 15, 2026K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekt
Elekta Solutions AB, SE
IYE
Jan 14, 2026K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
Brainlab SE, DE
IYE
Jan 5, 2026K252988ChartCheck (RADCH V1.6)
Radformation, Inc.
IYE
Dec 16, 2025K252919IDENTIFY (5.0)
Varian Medical Systems, Inc.
IYE
Nov 3, 2025K250392ZAP-X Radiosurgery System (ZAP-X)
Zap Surgical Systems, Inc.
IYE
Oct 24, 2025K250696AccuCheck
Manteia Technologies Co., Ltd., CN
IYE
Oct 17, 2025K250911MOSkin Radiation Measurement System
Electrogenics Labs, Ltd., AU
IYE
Oct 7, 2025K252948TrueBeam, TrueBeam STX, Edge and VitalBeam
Varian Medical Systems, Inc.
IYE
Sep 3, 2025K252174AquaCast Mask
Blessing Cathay Corporation, TW
IYE
Jun 23, 2025K243142Cranial 4Pi Immobilization
Brainlab AG, DE
IYE
May 19, 2025K243301MapRT
Vision Rt, Ltd., GB
IYE
May 16, 2025K250099Mobius3D (4.1)
Varian Medical Systems
IYE
Mar 19, 2025K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Pr
Macromedics BV, NL
IYE
Mar 18, 2025K241937Klarity SGRT System (ARSG-E1A, ARSG-E3A)
Klarity Medical & Equipment (GZ) Co., Ltd., CN
IYE
Feb 7, 2025K242957Identify (4.0)
Varian Medical Systems, Inc.
IYE
Jul 24, 2024K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
Brainlab AG, DE
IYE
May 31, 2024K232738BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla, DE
IYE
Apr 30, 2024K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
Varian Medical Systems, Inc.
IYE
Apr 12, 2024K232489VenusX
Linatech, LLC
IYE
Mar 29, 2024K233622AlignRT Plus
Vision Rt, Ltd., GB
IYE
Mar 29, 2024K232031LUNA 3D
Lap GmbH Laser Applikationen, DE
IYE
Jan 18, 2024K231573ThinkQA (Edition 2)
Dosisoft SA, FR
IYE
Jan 16, 2024K223234Delta4 Insight
Scandidos AB, SE
IYE
Jan 5, 2024K231273ArcherQA (V1.0)
Wisdom Technologies., Inc., CN
IYE
Dec 22, 2023K232293kallisio stentra™ oral stent
Kallisio, Inc.
IYE
Dec 21, 2023K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)
Varian Medical Systems, Inc.
IYE
Nov 15, 2023K231852BinkieRT
Papricalab, KR
IYE
Nov 3, 2023K232113Halcyon, Ethos Radiotherapy System
Varian Medical Systems, Inc.
IYE
Sep 12, 2023K231317TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.
IYE
Jul 25, 2023K230576IDENTIFY
Varian Medical Systems, Inc.
IYE
Jul 20, 2023K223834AccuCheck
Manteia Technologies Co., Ltd., CN
IYE
Jun 23, 2023K231185MapRT
Vision Rt, Ltd., GB
IYE
Jun 23, 2023K223159Radixact Treatment Delivery System
Accuray Incorporated
IYE
Jun 8, 2023K222762SIDDHARTH-II;IMPACT
Panacea Medical Technologies Pvt. , Ltd., IN
IYE
May 22, 2023K223839TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.
IYE
May 11, 2023K231052ExacTrac Dynamic 1.1.2
Brainlab AG, DE
IYE
Apr 10, 2023K230699ARIA Radiation Therapy Management (v18.0)
Varian Medical Systems, Inc.
IYE
Mar 31, 2023K230312Iris AirShuttle™
Qfix
IYE
Feb 23, 2023K223229MOSAIQ® OIS (Oncology Information System)
Elekta Solutions AB, SE
IYE

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