IYE
- Product code
- IYE
- Device name
- Accelerator, Linear, Medical
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.5050
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 38
- Summaries archived here
- 35 (direct download)
- 510(k) clearances (all years, FDA)
- 736 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (38)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260733 | 2026-08-26 | Manteia Technologies Co., Ltd. | MRIA Radiation Therapy Information System (MRIA) | |
| K261856 | 2026-08-03 | Varian Medical Systems, Inc. | Halcyon, Ethos Radiotherapy System (5.0) | |
| K252937 | 2026-06-12 | Dosisoft SA | ThinkQA 3 | FDA |
| K253004 | 2026-06-04 | Lap GmbH Laser Applikationen | LUNA 3D | |
| K260792 | 2026-05-08 | Stabilix, LLC | AerFrame Patient Immobilization System (AFPIS) | |
| K252258 | 2026-04-15 | Ptw-Freiburg Physikalisch-Technische-W… | VERIQA RT EPID 3D | FDA |
| K253962 | 2026-04-03 | Radformation, Inc. | ClearCheck (RADCC V2.7) | |
| K253012 | 2026-03-18 | Vision Rt, Ltd. | AlignRT Plus (8.0) | |
| K252977 | 2026-01-21 | Varian Medical Systems, Inc. | Halcyon, Ethos Radiotherapy System (5.0) | |
| K252188 | 2026-01-15 | Elekta Solutions AB | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harm… | |
| K254010 | 2026-01-14 | Brainlab SE | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | |
| K252988 | 2026-01-05 | Radformation, Inc. | ChartCheck (RADCH V1.6) | |
| K252919 | 2025-12-16 | Varian Medical Systems, Inc. | IDENTIFY (5.0) | |
| K250392 | 2025-11-03 | Zap Surgical Systems, Inc. | ZAP-X Radiosurgery System (ZAP-X) | |
| K250696 | 2025-10-24 | Manteia Technologies Co., Ltd. | AccuCheck | |
| K250911 | 2025-10-17 | Electrogenics Labs, Ltd. | MOSkin Radiation Measurement System | |
| K252948 | 2025-10-07 | Varian Medical Systems, Inc. | TrueBeam, TrueBeam STX, Edge and VitalBeam | |
| K252174 | 2025-09-03 | Blessing Cathay Corporation | AquaCast Mask | |
| K243142 | 2025-06-23 | Brainlab AG | Cranial 4Pi Immobilization | |
| K243301 | 2025-05-19 | Vision Rt, Ltd. | MapRT | |
| K250099 | 2025-05-16 | Varian Medical Systems | Mobius3D (4.1) | |
| K250429 | 2025-03-19 | Macromedics BV | DSPS-Prominent® baseplate, MR (113820); DSPS-Promin… | |
| K241937 | 2025-03-18 | Klarity Medical & Equipment (GZ) Co., … | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | FDA |
| K242957 | 2025-02-07 | Varian Medical Systems, Inc. | Identify (4.0) | |
| K240431 | 2024-07-24 | Brainlab AG | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | |
| K232738 | 2024-05-31 | Ptw-Freiburg Physikalisch-Technische-W… | BeamDose software (S080053); BEAMSCAN software, opti… | |
| K232923 | 2024-04-30 | Varian Medical Systems, Inc. | Ethos Treatment Management (3.0); Ethos Treatment Pl… | |
| K232489 | 2024-04-12 | Linatech, LLC | VenusX | |
| K233622 | 2024-03-29 | Vision Rt, Ltd. | AlignRT Plus | |
| K232031 | 2024-03-29 | Lap GmbH Laser Applikationen | LUNA 3D | |
| K231573 | 2024-01-18 | Dosisoft SA | ThinkQA (Edition 2) | |
| K223234 | 2024-01-16 | Scandidos AB | Delta4 Insight | |
| K231273 | 2024-01-05 | Wisdom Technologies., Inc. | ArcherQA (V1.0) | |
| K232293 | 2023-12-22 | Kallisio, Inc. | kallisio stentra oral stent | |
| K232870 | 2023-12-21 | Varian Medical Systems, Inc. | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) | |
| K231852 | 2023-11-15 | Papricalab | BinkieRT | |
| K232113 | 2023-11-03 | Varian Medical Systems, Inc. | Halcyon, Ethos Radiotherapy System | |
| K231317 | 2023-09-12 | Varian Medical Systems, Inc. | TrueBeam, TrueBeam STx, Edge, VitalBeam |
Official FDA classification page: IYE
Classification and pathway per current FDA publications. Data from openFDA (CC0).