Product code IYE
- Device name
- Accelerator, Linear, Medical
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5050
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261865 | AerFrame™ Alignment Laser Box (LBV2) | Stabilix, LLC | 2026-09-16 |
| K261718 | EZFluence (RADEZ V2) | Radformation, Inc. | 2026-08-31 |
| K260733 | MRIA Radiation Therapy Information System (MRIA) | Manteia Technologies Co., Ltd. | 2026-08-26 |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-08-03 |
| K252937 | ThinkQA 3 | Dosisoft SA | 2026-06-12 |
| K253004 | LUNA 3D | Lap GmbH Laser Applikationen | 2026-06-04 |
| K260792 | AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC | 2026-05-08 |
| K252258 | VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026-04-15 |
| K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | 2026-04-03 |
| K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | 2026-03-18 |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-01-21 |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB | 2026-01-15 |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | 2026-01-14 |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | 2026-01-05 |
| K252919 | IDENTIFY (5.0) | Varian Medical Systems, Inc. | 2025-12-16 |
| K250392 | ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. | 2025-11-03 |
| K250696 | AccuCheck | Manteia Technologies Co., Ltd. | 2025-10-24 |
| K250911 | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. | 2025-10-17 |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. | 2025-10-07 |
| K252174 | AquaCast Mask | Blessing Cathay Corporation | 2025-09-03 |
| K243142 | Cranial 4Pi Immobilization | Brainlab AG | 2025-06-23 |
| K243301 | MapRT | Vision Rt, Ltd. | 2025-05-19 |
| K250099 | Mobius3D (4.1) | Varian Medical Systems | 2025-05-16 |
| K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® C... | Macromedics BV | 2025-03-19 |
| K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2025-03-18 |
| K242957 | Identify (4.0) | Varian Medical Systems, Inc. | 2025-02-07 |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab AG | 2024-07-24 |
| K232738 | BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2024-05-31 |
| K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | Varian Medical Systems, Inc. | 2024-04-30 |
| K232489 | VenusX | Linatech, LLC | 2024-04-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850065937151 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937304 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937298 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937274 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937267 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937250 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937243 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937236 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937229 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937212 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937205 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937199 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937182 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937175 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937168 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937007 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937144 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937137 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937120 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937113 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937106 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937090 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937083 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937076 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937069 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937052 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937045 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937038 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937021 | eMotus | EMPNIA INC. | 2026-09-21 |
| 00850065937014 | eMotus | EMPNIA INC. | 2026-09-21 |