Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MUJ — Predicate Candidate Screening
257 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
240 days90th percentile
257clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260750 | Virtual Cone (1.0) | Varian Medical Systems, Inc. | 2026-07-08 | 124 | 0 |
| K253050 | RadOncAI | Informai | 2026-06-18 | 269 | 0 |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. | 2026-05-27 | 124 | 0 |
| K252784 | eXaSkin Plus | Anatomical Geometry S.L. | 2026-05-22 | 262 | 0 |
| K253078 | ART.1-US | Seetreat Pty, Ltd. | 2026-05-14 | 233 | 0 |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | 2026-03-18 | 237 | 0 |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026-02-19 | 20 | 0 |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026-02-19 | 237 | 0 |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 2025-12-23 | 91 | 0 |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | 2025-12-22 | 168 | 0 |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 2025-12-19 | 101 | 0 |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | 2025-11-20 | 234 | 0 |
| K250064 | Dose+ (1.0) | Mvision AI OY | 2025-09-04 | 237 | 0 |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elem | Brainlab AG | 2025-06-17 | 123 | 0 |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | 2025-04-17 | 203 | 2 |
| K242748 | Oncospace | Oncospace, Inc. | 2025-04-11 | 211 | 0 |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2 | RaySearch Laboratories AB (PUBL) | 2025-04-04 | 420 | 2 |
| K242822 | ART-Plan+ (v.3.0.0) | Therapanacea Sas | 2025-02-25 | 160 | 0 |
| K242463 | ARIA Radiation Therapy Management System (18.1) | Varian Medical Systems, Inc. | 2024-12-13 | 116 | 0 |
| K242378 | Eclipse Treatment Planning System (18.1) | Varian Medical Systems | 2024-12-11 | 124 | 0 |
| K240671 | XBeam (v2) | Xstrahl, Ltd. | 2024-12-04 | 268 | 0 |
| K241876 | Vitesse (5.0) | Varian Medical Systems | 2024-10-23 | 117 | 0 |
| K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | 2024-10-23 | 26 | 0 |
| K241318 | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | Adaptiiv Medical Technologies, Inc. | 2024-08-30 | 112 | 0 |
| K233236 | Radiance V5 | Gmv Soluciones Globales Internet S.A.U. | 2024-05-17 | 232 | 0 |
| K232799 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2024-04-26 | 227 | 0 |
| K234068 | ART-Plan (v.2.2.0) | Therapanacea Sas | 2024-04-22 | 122 | 0 |
| K232479 | ART-Plan | Therapanacea | 2023-12-22 | 128 | 0 |
| K231825 | Panther TPS | Prowess, Inc. | 2023-12-15 | 177 | 0 |
| K232400 | VariSeed (v10) | Varian Medical Systems | 2023-09-08 | 29 | 0 |
| K223724 | MOZI TPS | Manteia Technologies Co., Ltd. | 2023-07-10 | 209 | 0 |
| K230557 | Eclipse Treatment Planning System (v18.0) | Varian Medical Systems, Inc. | 2023-05-26 | 87 | 0 |
| K222728 | Radiation Planning Assistant (RPA) | University of Texas, MD Anderson Cancer Center | 2023-05-17 | 251 | 0 |
| K222312 | RayStation 12A | RaySearch Laboratories AB (PUBL) | 2023-03-29 | 240 | 6 |
| K223279 | RT Elements (4.0) | Brainlab AG | 2023-03-14 | 141 | 0 |
| K223233 | Monaco RTP System | Elekta Solutions AB | 2023-02-23 | 127 | 0 |
| K222803 | Oncospace | Oncospace, Inc. | 2023-02-02 | 139 | 0 |
| K220783 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2022-09-07 | 174 | 0 |
| K211841 | MRI Planner | Spectronic Medical AB | 2022-08-25 | 437 | 0 |
| K220582 | ClearCalc Model RADCA V2 | Radformation, Inc. | 2022-08-22 | 174 | 0 |
| K213787 | Monaco RTP System | Elekta Solutions AB | 2022-05-17 | 162 | 0 |
| K220141 | RayStation 11B | RaySearch Laboratories AB (PUBL) | 2022-04-15 | 87 | 5 |
| K212274 | INT Contour | Carina Medical, LLC | 2022-04-08 | 262 | 0 |
| K214081 | MRCAT Head & Neck | Philips OY | 2022-04-05 | 99 | 0 |
| K213438 | 3D Bolus Software Application, 3D Brachy Software Applicatio | Adaptiiv | 2022-01-19 | 89 | 0 |
| K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | 2021-09-08 | 84 | 5 |
| K211881 | AI Segmentation | Varian Medical Systems, Inc. | 2021-09-02 | 73 | 0 |
| K211379 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | 2021-07-30 | 87 | 1 |
| K211511 | decimal Bolus | .Decimal, LLC | 2021-07-01 | 48 | 0 |
| K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021-06-29 | 118 | 5 |
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