| 2026-08-03 |
K261856 |
Halcyon, Ethos Radiotherapy System (5.0) |
IYE |
— |
— |
| 2026-07-10 |
K261306 |
AI Contouring (VA10A) |
QKB |
Class II |
Radiology |
| 2026-07-08 |
K260750 |
Virtual Cone (1.0) |
MUJ |
Class II |
Radiology |
| 2026-06-04 |
K253026 |
Respiratory Gating for Scanners (2.1) |
JAK |
Class II |
Radiology |
| 2026-05-20 |
K252717 |
MAASTRO Rectal Applicator Set |
JAQ |
Class II |
Radiology |
| 2026-04-23 |
K252815 |
ProBeam 360 Proton Therapy System v3.0 |
LHN |
Class II |
Radiology |
| 2026-03-18 |
K252304 |
syngo.via RT Image Suite VC10 |
MUJ |
Class II |
Radiology |
| 2026-01-21 |
K252977 |
Halcyon, Ethos Radiotherapy System (5.0) |
IYE |
— |
— |
| 2025-12-16 |
K252919 |
IDENTIFY (5.0) |
IYE |
— |
— |
| 2025-11-19 |
K252884 |
Guided Aarhus Applicator Set |
JAQ |
Class II |
Radiology |
| 2025-10-07 |
K252948 |
TrueBeam, TrueBeam STX, Edge and VitalBeam |
IYE |
— |
— |
| 2025-05-16 |
K250099 |
Mobius3D (4.1) |
IYE |
— |
— |
| 2025-05-09 |
K250299 |
CT/ MR Tandem and Ovoid Set |
JAQ |
Class II |
Radiology |
| 2025-04-25 |
K250289 |
Intracavitary/Interstitial System |
JAQ |
Class II |
Radiology |
| 2025-03-03 |
K243939 |
Titanium Flexible Geometry FSD Applicator Set (GM11013400) |
JAQ |
Class II |
Radiology |
| 2025-02-07 |
K242957 |
Identify (4.0) |
IYE |
— |
— |
| 2025-01-17 |
K242608 |
Embozene Color-Advanced Microspheres |
KRD |
— |
— |
| 2025-01-10 |
K241764 |
Mould Probe MR Safe |
JAQ |
Class II |
Radiology |
| 2024-12-13 |
K242463 |
ARIA Radiation Therapy Management System (18.1) |
MUJ |
Class II |
Radiology |
| 2024-12-11 |
K242378 |
Eclipse Treatment Planning System (18.1) |
MUJ |
Class II |
Radiology |
| 2024-11-26 |
K242961 |
Intraluminal Applicator Set |
JAQ |
Class II |
Radiology |
| 2024-11-21 |
K242874 |
Gating Reflector Block |
JAK |
Class II |
Radiology |
| 2024-11-07 |
K241853 |
Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve |
JAQ |
Class II |
Radiology |
| 2024-10-29 |
K241965 |
Catheter Surface Flap Applicator Set (GM11011830) |
JAQ |
Class II |
Radiology |
| 2024-10-23 |
K241876 |
Vitesse (5.0) |
MUJ |
Class II |
Radiology |
| 2024-10-16 |
K242794 |
ONCOZENE Microspheres |
KRD |
— |
— |
| 2024-08-30 |
K241386 |
Heyman Packing Applicator Set (GM11004580) |
JAQ |
Class II |
Radiology |
| 2024-07-19 |
K240480 |
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) |
NEY |
Class II |
General, Plastic Surgery |
| 2024-05-29 |
K240784 |
Temperature Sensor Probe (ABL-18TP20) |
NEY |
Class II |
General, Plastic Surgery |
| 2024-05-09 |
K240495 |
Flexible Fixation Device for Gynecological Applicators (GM11001960) |
JAQ |
Class II |
Radiology |
| 2024-04-30 |
K232923 |
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) |
IYE |
— |
— |
| 2024-04-09 |
K232623 |
Universal Endometrial Applicator Set (GM11009840) |
JAQ |
Class II |
Radiology |
| 2024-02-01 |
K232949 |
Kelowna GYN and Crook Prostate Templates |
JAQ |
Class II |
Radiology |
| 2023-12-21 |
K232870 |
TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) |
IYE |
— |
— |
| 2023-11-03 |
K232113 |
Halcyon, Ethos Radiotherapy System |
IYE |
— |
— |
| 2023-10-06 |
K231863 |
ProBeam 360° Proton Therapy System v2.0 (Multiroom) |
LHN |
Class II |
Radiology |
| 2023-09-12 |
K231317 |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
IYE |
— |
— |
| 2023-09-08 |
K232400 |
VariSeed (v10) |
MUJ |
Class II |
Radiology |
| 2023-07-25 |
K230576 |
IDENTIFY |
IYE |
— |
— |
| 2023-05-26 |
K230557 |
Eclipse Treatment Planning System (v18.0) |
MUJ |
Class II |
Radiology |
| 2023-05-22 |
K223839 |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
IYE |
— |
— |
| 2023-04-10 |
K230699 |
ARIA Radiation Therapy Management (v18.0) |
IYE |
— |
— |
| 2023-03-28 |
K230271 |
ISOLIS Cryoprobe |
GEH |
Class II |
General, Plastic Surgery |
| 2023-03-13 |
K222775 |
Aarhus Applicator Set |
JAQ |
Class II |
Radiology |
| 2023-01-17 |
K222941 |
Halcyon, Ethos Radiotherapy System |
IYE |
— |
— |
| 2022-12-01 |
K221791 |
ProBeam 360° Proton Therapy System |
LHN |
Class II |
Radiology |
| 2022-09-14 |
K221797 |
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device |
JAQ |
Class II |
Radiology |
| 2022-06-17 |
K221408 |
ARIA Radiation Therapy Management (v16.1 MR3) |
IYE |
— |
— |
| 2022-06-15 |
K221448 |
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) |
IYE |
— |
— |
| 2022-06-03 |
K213977 |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
IYE |
— |
— |
| 2022-01-14 |
K213927 |
Respiratory Gating for Scanners v2.0 |
JAK |
Class II |
Radiology |
| 2022-01-05 |
K211149 |
Urethral Warming Catheter Kit |
GEH |
Class II |
General, Plastic Surgery |
| 2021-09-02 |
K211881 |
AI Segmentation |
MUJ |
Class II |
Radiology |
| 2021-08-20 |
K212294 |
Ethos Treatment Management, Ethos Treatment Planning |
IYE |
— |
— |
| 2021-04-20 |
K210835 |
Identify |
IYE |
— |
— |
| 2021-04-19 |
K203469 |
AI Segmentation |
MUJ |
Class II |
Radiology |
| 2021-02-12 |
K203766 |
4D Integrated Treatment Console |
MUJ |
Class II |
Radiology |
| 2021-01-14 |
K203669 |
Mobius3D |
IYE |
— |
— |
| 2020-08-17 |
K193240 |
Universal Cylinder Applicator Family |
JAQ |
Class II |
Radiology |
| 2020-08-11 |
K201588 |
CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice |
GEH |
Class II |
General, Plastic Surgery |
| 2020-07-10 |
K201607 |
Eclipse Treatment Planning System v16.1 |
MUJ |
Class II |
Radiology |
| 2020-04-03 |
K200608 |
Eclipse Treatment Planning System v16.0 |
MUJ |
Class II |
Radiology |
| 2020-02-10 |
K192377 |
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon |
IYE |
— |
— |