FDA Product Code
FDA Product Code IYE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5050
510(k) Clearances — 738 records · page 1 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261865 | AerFrame Alignment Laser Box (LBV2) | Stabilix, LLC | 2026-09-16 | Traditional | PDF ↗ |
| K261718 | EZFluence (RADEZ V2) | Radformation, Inc. | 2026-08-31 | Traditional | PDF ↗ |
| K260733 | MRIA Radiation Therapy Information System (MRIA) | Manteia Technologies Co., Ltd. | 2026-08-26 | Traditional | PDF ↗ |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-08-03 | Traditional | PDF ↗ |
| K252937 | ThinkQA 3 | Dosisoft SA | 2026-06-12 | Traditional | PDF ↗ |
| K253004 | LUNA 3D | Lap GmbH Laser Applikationen | 2026-06-04 | Traditional | PDF ↗ |
| K260792 | AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC | 2026-05-08 | Traditional | PDF ↗ |
| K252258 | VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026-04-15 | Traditional | PDF ↗ |
| K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | 2026-04-03 | Traditional | PDF ↗ |
| K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | 2026-03-18 | Traditional | PDF ↗ |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-01-21 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | 2026-01-14 | Special | PDF ↗ |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | 2026-01-05 | Traditional | PDF ↗ |
| K252919 | IDENTIFY (5.0) | Varian Medical Systems, Inc. | 2025-12-16 | Traditional | PDF ↗ |
| K250392 | ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. | 2025-11-03 | Traditional | PDF ↗ |
| K250696 | AccuCheck | Manteia Technologies Co., Ltd. | 2025-10-24 | Traditional | PDF ↗ |
| K250911 | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. | 2025-10-17 | Traditional | PDF ↗ |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. | 2025-10-07 | Traditional | PDF ↗ |
| K252174 | AquaCast Mask | Blessing Cathay Corporation | 2025-09-03 | Traditional | PDF ↗ |
| K243142 | Cranial 4Pi Immobilization | Brainlab AG | 2025-06-23 | Traditional | PDF ↗ |
| K243301 | MapRT | Vision Rt, Ltd. | 2025-05-19 | Traditional | PDF ↗ |
| K250099 | Mobius3D (4.1) | Varian Medical Systems | 2025-05-16 | Traditional | PDF ↗ |
| 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® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set | Macromedics BV | 2025-03-19 | Traditional | PDF ↗ |
| K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2025-03-18 | Traditional | PDF ↗ |
| K242957 | Identify (4.0) | Varian Medical Systems, Inc. | 2025-02-07 | Traditional | PDF ↗ |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab AG | 2024-07-24 | Traditional | PDF ↗ |
| K232738 | BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2024-05-31 | Traditional | PDF ↗ |
| K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | Varian Medical Systems, Inc. | 2024-04-30 | Traditional | PDF ↗ |
| K232489 | VenusX | Linatech, LLC | 2024-04-12 | Traditional | PDF ↗ |
| K233622 | AlignRT Plus | Vision Rt, Ltd. | 2024-03-29 | Traditional | PDF ↗ |
| K232031 | LUNA 3D | Lap GmbH Laser Applikationen | 2024-03-29 | Traditional | PDF ↗ |
| K231573 | ThinkQA (Edition 2) | Dosisoft SA | 2024-01-18 | Traditional | PDF ↗ |
| K223234 | Delta4 Insight | Scandidos AB | 2024-01-16 | Traditional | PDF ↗ |
| K231273 | ArcherQA (V1.0) | Wisdom Technologies., Inc. | 2024-01-05 | Traditional | PDF ↗ |
| K232293 | kallisio stentra oral stent | Kallisio, Inc. | 2023-12-22 | Traditional | PDF ↗ |
| K232870 | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) | Varian Medical Systems, Inc. | 2023-12-21 | Traditional | PDF ↗ |
| K231852 | BinkieRT | Papricalab | 2023-11-15 | Traditional | PDF ↗ |
| K232113 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023-11-03 | Traditional | PDF ↗ |
| K231317 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | 2023-09-12 | Traditional | PDF ↗ |
| K230576 | IDENTIFY | Varian Medical Systems, Inc. | 2023-07-25 | Traditional | PDF ↗ |
| K223834 | AccuCheck | Manteia Technologies Co., Ltd. | 2023-07-20 | Traditional | PDF ↗ |
| K223159 | Radixact Treatment Delivery System | Accuray Incorporated | 2023-06-23 | Traditional | PDF ↗ |
| K231185 | MapRT | Vision Rt, Ltd. | 2023-06-23 | Traditional | PDF ↗ |
| K222762 | SIDDHARTH-II;IMPACT | Panacea Medical Technologies Pvt. , Ltd. | 2023-06-08 | Traditional | PDF ↗ |
| K223839 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | 2023-05-22 | Traditional | PDF ↗ |
| K231052 | ExacTrac Dynamic 1.1.2 | Brainlab AG | 2023-05-11 | Special | PDF ↗ |
| K230699 | ARIA Radiation Therapy Management (v18.0) | Varian Medical Systems, Inc. | 2023-04-10 | Special | PDF ↗ |
| K230312 | Iris AirShuttle | Qfix | 2023-03-31 | Special | PDF ↗ |
| K223209 | Elekta Unity | Elekta Solutions AB | 2023-02-23 | Traditional | PDF ↗ |
| K223229 | MOSAIQ® OIS (Oncology Information System) | Elekta Solutions AB | 2023-02-23 | Traditional | PDF ↗ |
| K222977 | DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip | Macromedics BV | 2023-02-17 | Traditional | PDF ↗ |
| K222941 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023-01-17 | Traditional | PDF ↗ |
| K220539 | Klarity SRS Baseplate, Klarity Promise Baseplate | Klarity Medical & Equipment (GZ) Co., Ltd. | 2022-11-01 | Traditional | PDF ↗ |
| K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | 2022-08-23 | Traditional | PDF ↗ |
| K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | Macromedics BV | 2022-06-24 | Traditional | PDF ↗ |
| K221408 | ARIA Radiation Therapy Management (v16.1 MR3) | Varian Medical Systems, Inc. | 2022-06-17 | Special | PDF ↗ |
| K221448 | ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) | Varian Medical Systems, Inc. | 2022-06-15 | Special | PDF ↗ |
| K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | 2022-06-03 | Traditional | PDF ↗ |
| K213137 | INTDose | Carina Medical, LLC | 2022-05-13 | Traditional | PDF ↗ |
| K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips | Macromedics BV | 2022-05-11 | Traditional | PDF ↗ |
| K213526 | Aurora-RT | Magnettx Oncology Solutions , Ltd. | 2022-05-04 | Traditional | PDF ↗ |
| K220338 | ExacTrac Dynamic | Brainlab AG | 2022-04-29 | Traditional | PDF ↗ |
| K213370 | VERIQA | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2022-03-30 | Traditional | PDF ↗ |
| K213053 | Gold Anchor | Naslund Medical AB | 2022-01-06 | Traditional | PDF ↗ |
| K212958 | MRIdian Linac System | Viewray, Incorporated | 2021-12-14 | Traditional | PDF ↗ |
| K212583 | AlignRT Plus | Vision Rt, Ltd. | 2021-11-10 | Traditional | PDF ↗ |
| K210921 | TaiChiB | Our United Corporation | 2021-11-02 | Traditional | PDF ↗ |
| K212114 | Elekta Unity | Elekta Solutions AB | 2021-10-01 | Traditional | PDF ↗ |
| K212794 | Accuray Precision Treatment Planning System | Accuray Incorporated | 2021-09-30 | Special | PDF ↗ |
| K211760 | Panther OIS | Prowess, Inc. | 2021-09-28 | Traditional | PDF ↗ |
| K210894 | SIDDHARTH-II; IMPACT | Panacea Medical Technologies Pvt. , Ltd. | 2021-09-28 | Traditional | PDF ↗ |
| K212606 | BeamSite | Doseoptics, LLC | 2021-09-15 | Special | PDF ↗ |
| K203722 | RayPilot System | Micropos Medical AB | 2021-09-02 | Traditional | PDF ↗ |
| K212294 | Ethos Treatment Management, Ethos Treatment Planning | Varian Medical Systems, Inc. | 2021-08-20 | Special | PDF ↗ |
| K211663 | Zap-X Radiosurgical System | Zap Surgical Systems, Inc. | 2021-07-29 | Traditional | PDF ↗ |
| K211939 | ExacTrac Dynamic | Brainlab AG | 2021-07-22 | Special | PDF ↗ |
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | Elekta Limited | 2021-06-11 | Traditional | PDF ↗ |
| K211590 | Fiducial Marker | Carbon Medical Technologies, Inc. | 2021-06-10 | Special | PDF ↗ |
| K211001 | C-Qual M Breastboard; Monarch Overhead Arm Positioner | Medtec, Inc. Dba Civco Medical Solutions and Civco | 2021-05-20 | Traditional | PDF ↗ |
| K202747 | Klarity Bolus | Klarity Medical & Equipment (GZ) Co., Ltd. | 2021-05-14 | Traditional | PDF ↗ |
| K210835 | Identify | Varian Medical Systems, Inc. | 2021-04-20 | Special | PDF ↗ |
| K203387 | AlignRT Plus | Vision Rt, Ltd. | 2021-03-04 | Traditional | PDF ↗ |
| K203669 | Mobius3D | Varian Medical Systems, Inc. | 2021-01-14 | Special | PDF ↗ |
| K202412 | ClearRT Helical kVCT for the Radixact Treatment Delivery System | Accuray Incorporated | 2020-12-18 | Traditional | PDF ↗ |
| K203172 | MOSAIQ Oncology Information System | Elekta Solutions AB | 2020-12-18 | Traditional | PDF ↗ |
| K200940 | BeamSite | Doseoptics, LLC | 2020-12-11 | Traditional | PDF ↗ |
| K203173 | ExacTrac Dynamic | Brainlab AG | 2020-11-12 | Special | PDF ↗ |
| K202050 | Cranial 4Pi Immobilization | Brainlab AG | 2020-08-19 | Special | PDF ↗ |
| K202068 | The AIO Solution 3.0 | Orfit Industries NV | 2020-08-14 | Traditional | PDF ↗ |
| K193207 | TaiChiA | Our United Corporation | 2020-08-07 | Traditional | PDF ↗ |
| K201276 | ExacTrac Dynamic | Brainlab AG | 2020-07-13 | Traditional | PDF ↗ |
| K200652 | Lollipop BiteBlock | Radtec Medical Devices, Inc. | 2020-07-06 | Traditional | PDF ↗ |
| K201119 | ChartCheck | Radformation, Inc. | 2020-06-26 | Traditional | PDF ↗ |
| K201117 | Gold Anchor | Naslund Medical AB | 2020-06-11 | Traditional | PDF ↗ |
| K200907 | Thales 3D Mr Scanner | Lap GmbH Laser Applikationen | 2020-06-03 | Traditional | PDF ↗ |
| K200435 | Catalyst+, Catalyst+ HD | C-Rad Positioning AB | 2020-05-07 | Traditional | PDF ↗ |
| K192405 | Image Guidance System for Radiotherapy | Jiangsu Rayer Medical Technology Co., Ltd. | 2020-05-01 | Traditional | PDF ↗ |
| K200600 | Sentinel | C-Rad Positioning AB | 2020-04-20 | Special | PDF ↗ |
| K190978 | RefleXion Medical Radiotherapy System | Reflexion Medical, Inc. | 2020-03-12 | Traditional | PDF ↗ |
Product code IYE · Class II · Radiology. Data: openFDA.