| Halcyon, Ethos Radiotherapy System (5.0) (K261856) | Varian Medical Systems, Inc. | 2026-08-03 |
| ThinkQA 3 (K252937) | Dosisoft SA | 2026-06-12 |
| LUNA 3D (K253004) | Lap GmbH Laser Applikationen | 2026-06-04 |
| AerFrame Patient Immobilization System (AFPIS) (K260792) | Stabilix, LLC | 2026-05-08 |
| VERIQA RT EPID 3D (K252258) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026-04-15 |
| ClearCheck (RADCC V2.7) (K253962) | Radformation, Inc. | 2026-04-03 |
| AlignRT Plus (8.0) (K253012) | Vision Rt, Ltd. | 2026-03-18 |
| Halcyon, Ethos Radiotherapy System (5.0) (K252977) | Varian Medical Systems, Inc. | 2026-01-21 |
| EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (K252188) | Elekta Solutions AB | 2026-01-15 |
| ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (K254010) | Brainlab SE | 2026-01-14 |
| ChartCheck (RADCH V1.6) (K252988) | Radformation, Inc. | 2026-01-05 |
| IDENTIFY (5.0) (K252919) | Varian Medical Systems, Inc. | 2025-12-16 |
| ZAP-X Radiosurgery System (ZAP-X) (K250392) | Zap Surgical Systems, Inc. | 2025-11-03 |
| AccuCheck (K250696) | Manteia Technologies Co., Ltd. | 2025-10-24 |
| MOSkin Radiation Measurement System (K250911) | Electrogenics Labs, Ltd. | 2025-10-17 |
| TrueBeam, TrueBeam STX, Edge and VitalBeam (K252948) | Varian Medical Systems, Inc. | 2025-10-07 |
| AquaCast Mask (K252174) | Blessing Cathay Corporation | 2025-09-03 |
| Cranial 4Pi Immobilization (K243142) | Brainlab AG | 2025-06-23 |
| MapRT (K243301) | Vision Rt, Ltd. | 2025-05-19 |
| Mobius3D (4.1) (K250099) | Varian Medical Systems | 2025-05-16 |
| 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 (K250429) | Macromedics BV | 2025-03-19 |
| Klarity SGRT System (ARSG-E1A, ARSG-E3A) (K241937) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2025-03-18 |
| Identify (4.0) (K242957) | Varian Medical Systems, Inc. | 2025-02-07 |
| ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface (K240431) | Brainlab AG | 2024-07-24 |
| BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) (K232738) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2024-05-31 |
| Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) (K232923) | Varian Medical Systems, Inc. | 2024-04-30 |
| VenusX (K232489) | Linatech, LLC | 2024-04-12 |
| AlignRT Plus (K233622) | Vision Rt, Ltd. | 2024-03-29 |
| LUNA 3D (K232031) | Lap GmbH Laser Applikationen | 2024-03-29 |
| ThinkQA (Edition 2) (K231573) | Dosisoft SA | 2024-01-18 |
| Delta4 Insight (K223234) | Scandidos AB | 2024-01-16 |
| ArcherQA (V1.0) (K231273) | Wisdom Technologies., Inc. | 2024-01-05 |
| kallisio stentra™ oral stent (K232293) | Kallisio, Inc. | 2023-12-22 |
| TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) (K232870) | Varian Medical Systems, Inc. | 2023-12-21 |
| BinkieRT (K231852) | Papricalab | 2023-11-15 |
| Halcyon, Ethos Radiotherapy System (K232113) | Varian Medical Systems, Inc. | 2023-11-03 |
| TrueBeam, TrueBeam STx, Edge, VitalBeam (K231317) | Varian Medical Systems, Inc. | 2023-09-12 |
| IDENTIFY (K230576) | Varian Medical Systems, Inc. | 2023-07-25 |
| AccuCheck (K223834) | Manteia Technologies Co., Ltd. | 2023-07-20 |
| Radixact Treatment Delivery System (K223159) | Accuray Incorporated | 2023-06-23 |
| MapRT (K231185) | Vision Rt, Ltd. | 2023-06-23 |
| SIDDHARTH-II;IMPACT (K222762) | Panacea Medical Technologies Pvt. , Ltd. | 2023-06-08 |
| TrueBeam, TrueBeam STx, Edge, VitalBeam (K223839) | Varian Medical Systems, Inc. | 2023-05-22 |
| ExacTrac Dynamic 1.1.2 (K231052) | Brainlab AG | 2023-05-11 |
| ARIA Radiation Therapy Management (v18.0) (K230699) | Varian Medical Systems, Inc. | 2023-04-10 |
| Iris AirShuttle™ (K230312) | Qfix | 2023-03-31 |
| Elekta Unity (K223209) | Elekta Solutions AB | 2023-02-23 |
| MOSAIQ® OIS (Oncology Information System) (K223229) | Elekta Solutions AB | 2023-02-23 |
| DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip (K222977) | Macromedics BV | 2023-02-17 |
| Halcyon, Ethos Radiotherapy System (K222941) | Varian Medical Systems, Inc. | 2023-01-17 |
| Klarity SRS Baseplate, Klarity Promise Baseplate (K220539) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2022-11-01 |
| ClearCheck Model RADCC V2 (K220583) | Radformation, Inc. | 2022-08-23 |
| FlexBoardTM, EagleBoardTM, BreastBoard SXTM (K213439) | Macromedics BV | 2022-06-24 |
| ARIA Radiation Therapy Management (v16.1 MR3) (K221408) | Varian Medical Systems, Inc. | 2022-06-17 |
| ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) (K221448) | Varian Medical Systems, Inc. | 2022-06-15 |
| TrueBeam, TrueBeam STx, Edge, VitalBeam (K213977) | Varian Medical Systems, Inc. | 2022-06-03 |
| INTDose (K213137) | Carina Medical, LLC | 2022-05-13 |
| VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips (K212909) | Macromedics BV | 2022-05-11 |
| Aurora-RT (K213526) | Magnettx Oncology Solutions , Ltd. | 2022-05-04 |
| ExacTrac Dynamic (K220338) | Brainlab AG | 2022-04-29 |
| VERIQA (K213370) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2022-03-30 |
| Gold Anchor (K213053) | Naslund Medical AB | 2022-01-06 |
| MRIdian Linac System (K212958) | Viewray, Incorporated | 2021-12-14 |
| AlignRT Plus (K212583) | Vision Rt, Ltd. | 2021-11-10 |
| TaiChiB (K210921) | Our United Corporation | 2021-11-02 |
| Elekta Unity (K212114) | Elekta Solutions AB | 2021-10-01 |
| Accuray Precision Treatment Planning System (K212794) | Accuray Incorporated | 2021-09-30 |
| SIDDHARTH-II; IMPACT (K210894) | Panacea Medical Technologies Pvt. , Ltd. | 2021-09-28 |
| Panther OIS (K211760) | Prowess, Inc. | 2021-09-28 |
| BeamSite (K212606) | Doseoptics, LLC | 2021-09-15 |
| RayPilot System (K203722) | Micropos Medical AB | 2021-09-02 |
| Ethos Treatment Management, Ethos Treatment Planning (K212294) | Varian Medical Systems, Inc. | 2021-08-20 |
| Zap-X Radiosurgical System (K211663) | Zap Surgical Systems, Inc. | 2021-07-29 |
| ExacTrac Dynamic (K211939) | Brainlab AG | 2021-07-22 |
| Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (K210500) | Elekta Limited | 2021-06-11 |
| Fiducial Marker (K211590) | Carbon Medical Technologies, Inc. | 2021-06-10 |
| C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner (K211001) | Medtec, Inc. Dba Civco Medical Solutions and Civco | 2021-05-20 |
| Klarity Bolus (K202747) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2021-05-14 |
| Identify (K210835) | Varian Medical Systems, Inc. | 2021-04-20 |
| AlignRT Plus (K203387) | Vision Rt, Ltd. | 2021-03-04 |
| Mobius3D (K203669) | Varian Medical Systems, Inc. | 2021-01-14 |
| MOSAIQ Oncology Information System (K203172) | Elekta Solutions AB | 2020-12-18 |
| ClearRT Helical kVCT for the Radixact Treatment Delivery System (K202412) | Accuray Incorporated | 2020-12-18 |
| BeamSite (K200940) | Doseoptics, LLC | 2020-12-11 |
| ExacTrac Dynamic (K203173) | Brainlab AG | 2020-11-12 |
| Cranial 4Pi Immobilization (K202050) | Brainlab AG | 2020-08-19 |
| The AIO Solution 3.0 (K202068) | Orfit Industries NV | 2020-08-14 |
| TaiChiA (K193207) | Our United Corporation | 2020-08-07 |
| ExacTrac Dynamic (K201276) | Brainlab AG | 2020-07-13 |
| Lollipop BiteBlock (K200652) | Radtec Medical Devices, Inc. | 2020-07-06 |
| ChartCheck (K201119) | Radformation, Inc. | 2020-06-26 |
| Gold Anchor (K201117) | Naslund Medical AB | 2020-06-11 |
| Thales 3D Mr Scanner (K200907) | Lap GmbH Laser Applikationen | 2020-06-03 |
| Catalyst+, Catalyst+ HD (K200435) | C-Rad Positioning AB | 2020-05-07 |
| Image Guidance System for Radiotherapy (K192405) | Jiangsu Rayer Medical Technology Co., Ltd. | 2020-05-01 |
| Sentinel (K200600) | C-Rad Positioning AB | 2020-04-20 |
| RefleXion Medical Radiotherapy System (K190978) | Reflexion Medical, Inc. | 2020-03-12 |
| Alta Multipurpose Device (K193243) | Qfix | 2020-02-28 |
| Beamscan MR (K191646) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2020-02-21 |
| Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon (K192377) | Varian Medical Systems, Inc. | 2020-02-10 |