Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IYE · Predicate Candidate Screening
735 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
264 days90th percentile
735clearances 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 |
| K252937 | ThinkQA 3 | Dosisoft SA | 2026-06-12 | 270 | 0 |
| K253004 | LUNA 3D | Lap GmbH Laser Applikationen | 2026-06-04 | 258 | 0 |
| K260792 | AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC | 2026-05-08 | 58 | 0 |
| K252258 | VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026-04-15 | 268 | 0 |
| K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | 2026-04-03 | 113 | 0 |
| K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | 2026-03-18 | 180 | 0 |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-01-21 | 126 | 0 |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro) | Elekta Solutions AB | 2026-01-15 | 185 | 0 |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | 2026-01-14 | 30 | 0 |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | 2026-01-05 | 109 | 0 |
| K252919 | IDENTIFY (5.0) | Varian Medical Systems, Inc. | 2025-12-16 | 95 | 0 |
| K250392 | ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. | 2025-11-03 | 264 | 0 |
| K250696 | AccuCheck | Manteia Technologies Co., Ltd. | 2025-10-24 | 231 | 0 |
| K250911 | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. | 2025-10-17 | 205 | 0 |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. | 2025-10-07 | 21 | 0 |
| K252174 | AquaCast Mask | Blessing Cathay Corporation | 2025-09-03 | 54 | 0 |
| K243142 | Cranial 4Pi Immobilization | Brainlab AG | 2025-06-23 | 266 | 0 |
| K243301 | MapRT | Vision Rt, Ltd. | 2025-05-19 | 213 | 0 |
| K250099 | Mobius3D (4.1) | Varian Medical Systems | 2025-05-16 | 122 | 0 |
| K250429 | DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® base | Macromedics BV | 2025-03-19 | 33 | 0 |
| K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2025-03-18 | 259 | 0 |
| K242957 | Identify (4.0) | Varian Medical Systems, Inc. | 2025-02-07 | 135 | 0 |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab AG | 2024-07-24 | 161 | 0 |
| K232738 | BeamDose software (S080053); BEAMSCAN software, option refer | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2024-05-31 | 267 | 0 |
| K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning ( | Varian Medical Systems, Inc. | 2024-04-30 | 224 | 0 |
| K232489 | VenusX | Linatech, LLC | 2024-04-12 | 239 | 0 |
| K233622 | AlignRT Plus | Vision Rt, Ltd. | 2024-03-29 | 137 | 0 |
| K232031 | LUNA 3D | Lap GmbH Laser Applikationen | 2024-03-29 | 266 | 0 |
| K231573 | ThinkQA (Edition 2) | Dosisoft SA | 2024-01-18 | 232 | 0 |
| K223234 | Delta4 Insight | Scandidos AB | 2024-01-16 | 454 | 0 |
| K231273 | ArcherQA (V1.0) | Wisdom Technologies., Inc. | 2024-01-05 | 248 | 0 |
| K232293 | kallisio stentra™ oral stent | Kallisio, Inc. | 2023-12-22 | 143 | 0 |
| K232870 | TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) | Varian Medical Systems, Inc. | 2023-12-21 | 97 | 0 |
| K231852 | BinkieRT | Papricalab | 2023-11-15 | 145 | 0 |
| K232113 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023-11-03 | 112 | 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 |
| K223834 | AccuCheck | Manteia Technologies Co., Ltd. | 2023-07-20 | 210 | 0 |
| K223159 | Radixact Treatment Delivery System | Accuray Incorporated | 2023-06-23 | 259 | 0 |
| K231185 | MapRT | Vision Rt, Ltd. | 2023-06-23 | 58 | 0 |
| K222762 | SIDDHARTH-II;IMPACT | Panacea Medical Technologies Pvt. , Ltd. | 2023-06-08 | 268 | 0 |
| K223839 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | 2023-05-22 | 151 | 0 |
| K231052 | ExacTrac Dynamic 1.1.2 | Brainlab AG | 2023-05-11 | 28 | 0 |
| K230699 | ARIA Radiation Therapy Management (v18.0) | Varian Medical Systems, Inc. | 2023-04-10 | 28 | 0 |
| K230312 | Iris AirShuttle™ | Qfix | 2023-03-31 | 56 | 0 |
| K223209 | Elekta Unity | Elekta Solutions AB | 2023-02-23 | 129 | 0 |
| K223229 | MOSAIQ® OIS (Oncology Information System) | Elekta Solutions AB | 2023-02-23 | 128 | 4 |
| K222977 | DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchS | Macromedics BV | 2023-02-17 | 142 | 0 |
| K222941 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | 2023-01-17 | 113 | 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