Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Varian Medical Systems, Inc. — Predicate Candidate Screening
172 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
231 days90th percentile
172clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261856 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-08-03 | 60 | 0 |
| K260750 | Virtual Cone (1.0) | Varian Medical Systems, Inc. | 2026-07-08 | 124 | 0 |
| K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | 2026-06-04 | 258 | 0 |
| K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | 2026-04-23 | 231 | 0 |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | 2026-03-18 | 237 | 0 |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-01-21 | 126 | 0 |
| K252919 | IDENTIFY (5.0) | Varian Medical Systems, Inc. | 2025-12-16 | 95 | 0 |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. | 2025-10-07 | 21 | 0 |
| K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | 2025-05-09 | 98 | 0 |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | 2025-03-03 | 73 | 0 |
| K242957 | Identify (4.0) | Varian Medical Systems, Inc. | 2025-02-07 | 135 | 0 |
| K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | 2025-01-17 | 136 | 0 |
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | 2025-01-10 | 204 | 0 |
| K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | 2024-12-13 | 116 | 0 |
| K242874 | Gating Reflector Block | Varian Medical Systems, Inc. | 2024-11-21 | 59 | 0 |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smi | Varian Medical Systems, Inc. | 2024-11-07 | 133 | 0 |
| K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | 2024-10-16 | 30 | 0 |
| K241386 | Heyman Packing Applicator Set (GM11004580) | Varian Medical Systems, Inc. | 2024-08-30 | 107 | 0 |
| K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); Int | Varian Medical Systems, Inc. | 2024-07-19 | 150 | 0 |
| K240784 | Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. | 2024-05-29 | 69 | 0 |
| K240495 | Flexible Fixation Device for Gynecological Applicators (GM11 | Varian Medical Systems, Inc. | 2024-05-09 | 79 | 0 |
| K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning ( | Varian Medical Systems, Inc. | 2024-04-30 | 224 | 0 |
| K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | 2024-04-09 | 224 | 0 |
| K232949 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | 2024-02-01 | 134 | 0 |
| K232870 | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) | Varian Medical Systems, Inc. | 2023-12-21 | 97 | 0 |
| K232113 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023-11-03 | 112 | 0 |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023-10-06 | 105 | 0 |
| K231317 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | 2023-09-12 | 127 | 0 |
| K230576 | IDENTIFY | Varian Medical Systems, Inc. | 2023-07-25 | 146 | 0 |
| K230557 | Eclipse Treatment Planning System (v18.0) | Varian Medical Systems, Inc. | 2023-05-26 | 87 | 0 |
| K223839 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | 2023-05-22 | 151 | 0 |
| K230699 | ARIA Radiation Therapy Management (v18.0) | Varian Medical Systems, Inc. | 2023-04-10 | 28 | 0 |
| K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | 2023-03-28 | 56 | 0 |
| K222775 | Aarhus Applicator Set | Varian Medical Systems, Inc. | 2023-03-13 | 180 | 0 |
| K222941 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023-01-17 | 113 | 0 |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022-12-01 | 163 | 0 |
| K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transf | Varian Medical Systems, Inc. | 2022-09-14 | 85 | 0 |
| K221408 | ARIA Radiation Therapy Management (v16.1 MR3) | Varian Medical Systems, Inc. | 2022-06-17 | 32 | 0 |
| K221448 | ARIA Radiation Therapy Management (v15.8), Eclipse Treatment | Varian Medical Systems, Inc. | 2022-06-15 | 28 | 0 |
| K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | 2022-06-03 | 165 | 0 |
| K213927 | Respiratory Gating for Scanners v2.0 | Varian Medical Systems, Inc. | 2022-01-14 | 29 | 0 |
| K211149 | Urethral Warming Catheter Kit | Varian Medical Systems, Inc. | 2022-01-05 | 261 | 0 |
| K211881 | AI Segmentation | Varian Medical Systems, Inc. | 2021-09-02 | 73 | 0 |
| K212294 | Ethos Treatment Management, Ethos Treatment Planning | Varian Medical Systems, Inc. | 2021-08-20 | 29 | 0 |
| K210835 | Identify | Varian Medical Systems, Inc. | 2021-04-20 | 29 | 0 |
| K203469 | AI Segmentation | Varian Medical Systems, Inc. | 2021-04-19 | 145 | 0 |
| K203766 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | 2021-02-12 | 51 | 0 |
| K203669 | Mobius3D | Varian Medical Systems, Inc. | 2021-01-14 | 29 | 0 |
| K193240 | Universal Cylinder Applicator Family | Varian Medical Systems, Inc. | 2020-08-17 | 266 | 0 |
| K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round | Varian Medical Systems, Inc. | 2020-08-11 | 60 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda