IYE
- 产品代码
- IYE
- 器械名称
- Accelerator, Linear, Medical
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.5050
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 736 件
该代码近三年的 510(k)（38 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260733 | 2026-08-26 | Manteia Technologies Co., Ltd. | MRIA Radiation Therapy Information System (MRIA) 摘要 |
| K261856 | 2026-08-03 | Varian Medical Systems, Inc. | Halcyon, Ethos Radiotherapy System (5.0) 摘要 |
| K252937 | 2026-06-12 | Dosisoft SA | ThinkQA 3 摘要 |
| K253004 | 2026-06-04 | Lap GmbH Laser Applikationen | LUNA 3D 摘要 |
| K260792 | 2026-05-08 | Stabilix, LLC | AerFrame Patient Immobilization System (AFPIS) 摘要 |
| K252258 | 2026-04-15 | Ptw-Freiburg Physikalisch-Technische-W | VERIQA RT EPID 3D 摘要 |
| K253962 | 2026-04-03 | Radformation, Inc. | ClearCheck (RADCC V2.7) 摘要 |
| K253012 | 2026-03-18 | Vision Rt, Ltd. | AlignRT Plus (8.0) 摘要 |
| K252977 | 2026-01-21 | Varian Medical Systems, Inc. | Halcyon, Ethos Radiotherapy System (5.0) 摘要 |
| K252188 | 2026-01-15 | Elekta Solutions AB | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harm 摘要 |
| K254010 | 2026-01-14 | Brainlab SE | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface 摘要 |
| K252988 | 2026-01-05 | Radformation, Inc. | ChartCheck (RADCH V1.6) 摘要 |
| K252919 | 2025-12-16 | Varian Medical Systems, Inc. | IDENTIFY (5.0) 摘要 |
| K250392 | 2025-11-03 | Zap Surgical Systems, Inc. | ZAP-X Radiosurgery System (ZAP-X) 摘要 |
| K250696 | 2025-10-24 | Manteia Technologies Co., Ltd. | AccuCheck 摘要 |
| K250911 | 2025-10-17 | Electrogenics Labs, Ltd. | MOSkin Radiation Measurement System 摘要 |
| K252948 | 2025-10-07 | Varian Medical Systems, Inc. | TrueBeam, TrueBeam STX, Edge and VitalBeam 摘要 |
| K252174 | 2025-09-03 | Blessing Cathay Corporation | AquaCast Mask 摘要 |
| K243142 | 2025-06-23 | Brainlab AG | Cranial 4Pi Immobilization 摘要 |
| K243301 | 2025-05-19 | Vision Rt, Ltd. | MapRT 摘要 |
| K250099 | 2025-05-16 | Varian Medical Systems | Mobius3D (4.1) 摘要 |
| K250429 | 2025-03-19 | Macromedics BV | DSPS-Prominent® baseplate, MR (113820); DSPS-Promin 摘要 |
| K241937 | 2025-03-18 | Klarity Medical & Equipment (GZ) Co., | Klarity SGRT System (ARSG-E1A, ARSG-E3A) 摘要 |
| K242957 | 2025-02-07 | Varian Medical Systems, Inc. | Identify (4.0) 摘要 |
| K240431 | 2024-07-24 | Brainlab AG | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface 摘要 |
| K232738 | 2024-05-31 | Ptw-Freiburg Physikalisch-Technische-W | BeamDose software (S080053); BEAMSCAN software, opti 摘要 |
| K232923 | 2024-04-30 | Varian Medical Systems, Inc. | Ethos Treatment Management (3.0); Ethos Treatment Pl 摘要 |
| K232489 | 2024-04-12 | Linatech, LLC | VenusX 摘要 |
| K233622 | 2024-03-29 | Vision Rt, Ltd. | AlignRT Plus 摘要 |
| K232031 | 2024-03-29 | Lap GmbH Laser Applikationen | LUNA 3D 摘要 |
| K231573 | 2024-01-18 | Dosisoft SA | ThinkQA (Edition 2) 摘要 |
| K223234 | 2024-01-16 | Scandidos AB | Delta4 Insight 摘要 |
| K231273 | 2024-01-05 | Wisdom Technologies., Inc. | ArcherQA (V1.0) 摘要 |
| K232293 | 2023-12-22 | Kallisio, Inc. | kallisio stentra oral stent 摘要 |
| K232870 | 2023-12-21 | Varian Medical Systems, Inc. | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) 摘要 |
| K231852 | 2023-11-15 | Papricalab | BinkieRT 摘要 |
| K232113 | 2023-11-03 | Varian Medical Systems, Inc. | Halcyon, Ethos Radiotherapy System 摘要 |
| K231317 | 2023-09-12 | Varian Medical Systems, Inc. | TrueBeam, TrueBeam STx, Edge, VitalBeam 摘要 |
FDA 官方分类页： IYE
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。