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 |
|---|---|---|---|
| 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 |
| K232031 | LUNA 3D | Lap GmbH Laser Applikationen | 2024-03-29 |
| K233622 | AlignRT Plus | Vision Rt, Ltd. | 2024-03-29 |
| K231573 | ThinkQA (Edition 2) | Dosisoft SA | 2024-01-18 |
| K223234 | Delta4 Insight | Scandidos AB | 2024-01-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840510401450 | KLARITY MEDICAL | Klarity Medical Products, LLC | 2026-08-03 |
| 05056190501211 | AlignRT Plus | VISION RT LIMITED | 2026-07-30 |
| 00840510401443 | KLARITY MEDICAL | Klarity Medical Products, LLC | 2026-07-24 |
| 00840510401436 | KLARITY MEDICAL | Klarity Medical Products, LLC | 2026-07-22 |
| 00840510401429 | KLARITY MEDICAL | Klarity Medical Products, LLC | 2026-07-08 |
| 00840510401412 | KLARITY MEDICAL | Klarity Medical Products, LLC | 2026-07-08 |
| 00840510401405 | KLARITY MEDICAL | Klarity Medical Products, LLC | 2026-06-23 |
| 00840510401399 | KLARITY MEDICAL | Klarity Medical Products, LLC | 2026-06-23 |
| 00840510401382 | KLARITY MEDICAL | Klarity Medical Products, LLC | 2026-06-23 |
| 00840510401375 | KLARITY MEDICAL | Klarity Medical Products, LLC | 2026-06-22 |
| 00841439115312 | MultiFix 2 - JointGlow | Qfix | 2026-06-04 |
| 00841439115343 | MultiFix Indexing Post | Qfix | 2026-06-04 |
| 00841439115336 | Extremity Riser - JointGlow | Qfix | 2026-06-04 |
| 00841439115329 | Extremity Riser | Qfix | 2026-06-04 |
| 00841439115305 | MultiFix 2 | Qfix | 2026-06-04 |
| 07350007952202 | Raypilot Receiver | Micropos Medical AB (Publ) | 2025-03-12 |
| 07350007951045 | Raypilot Hypocath | Micropos Medical AB (Publ) | 2023-04-04 |
| 07350007951052 | Raypilot Viewcath | Micropos Medical AB (Publ) | 2023-04-04 |
| 07350007952219 | Raypilot Extension Plate | Micropos Medical AB (Publ) | 2023-04-04 |
| 07350007953049 | Raypilot Software | Micropos Medical AB (Publ) | 2023-04-04 |
| 00841439114391 | AccuForm™ Cushion | MEDTEC, INC. | 2023-03-11 |
| 00841439113844 | Vac-Lok™ Cushion | MEDTEC, INC. | 2022-03-24 |
| 00841439109793 | Fiducial Markers | MEDTEC, INC. | 2017-08-02 |
| 00841439109779 | Fiducial Marker Kit | MEDTEC, INC. | 2017-08-02 |
| 00841439109755 | Fiducial Marker Kit | MEDTEC, INC. | 2017-08-02 |
| 00841439107591 | Lok-Bar™ | MEDTEC, INC. | 2017-08-02 |
| 00841439103098 | AccuForm™ Cushion | MEDTEC, INC. | 2017-08-02 |
| 00841439103081 | AccuForm™ Cushion | MEDTEC, INC. | 2017-08-02 |
| 00841439103036 | AccuForm™ Cushion | MEDTEC, INC. | 2017-08-02 |
| 00841439103029 | AccuForm™ Cushion | MEDTEC, INC. | 2017-08-02 |