IYEFDA Class 2 · 21 CFR 892.5050
Accelerator, Linear, Medical
Device family · Radiology
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
731
Manufacturers
68
Flagged signals
14
Adverse-event reports
1,753
Code matrix
| FDA product code | IYE |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2011 | 4 | 120.9 | 364 |
| Other | 2012 | 3 | 90.7 | 184 |
| Other | 2011 | 22 | 72.8 | 1,489 |
| Other | 2012 | 3 | 60.5 | 121 |
| Other | 2010 | 15 | 49.6 | 668 |
| Other | 2012 | 6 | 19.9 | 90 |
| Other | 2010 | 3 | 16.8 | 30 |
| Other | 2013 | 4 | 13.2 | 34 |
| Other | 2012 | 4 | 6.1 | 12 |
| Other | 2011 | 4 | 6.1 | 12 |
| Other | 2013 | 3 | 6.0 | 8 |
| Other | 2012 | 3 | 6.0 | 8 |
| Other | 2010 | 3 | 4.6 | 5 |
| Injury | 2022 | 6 | 2.6 | 7 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 1,753 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Varian Medical Systems, Inc. | 69 | 2026 | — |
| Varian Assoc., Inc. | 27 | 1999 | — |
| Brainlab AG | 21 | 2025 | — |
| MEDTEC, INC. | 20 | 2014 | — |
| Siemens Medical Solutions USA, Inc. | 18 | 2018 | — |
| Accuray Incorporated | 15 | 2023 | — |
| Philips Medical Systems, Inc. | 11 | 1996 | — |
| Sun Nuclear Corporation | 11 | 2017 | — |
| DIREX SYSTEMS CORP. | 9 | 2010 | — |
| SUN NUCLEAR CORP. | 8 | 2010 | — |
| Orfit Industries NV | 8 | 2020 | — |
| Radionics, Inc. | 7 | 1999 | — |
| ELEKTA LIMITED | 7 | 2021 | — |
| Qfix | 6 | 2023 | — |
| MATH RESOLUTIONS, LLC | 6 | 2016 | — |
| C-Rad Positioning AB | 6 | 2020 | — |
| Radformation, Inc. | 6 | 2026 | — |
| Adac Laboratories | 6 | 1996 | — |
| Medical Intelligence Medizintechnik GmbH | 5 | 2015 | — |
| Victoreen, Inc. | 5 | 1997 | — |
| Elekta Solutions AB | 5 | 2026 | — |
| Mick Radio-Nuclear Instruments, Inc. | 5 | 2000 | — |
| Scandidos AB | 5 | 2024 | — |
| Naslund Medical AB | 4 | 2022 | — |
| Diacor, Inc. | 4 | 2005 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
VERIQA RT EPID 3D · Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla510(k) · 2026-04-15
ClearCheck (RADCC V2.7) · Radformation, Inc.510(k) · 2026-04-03
AlignRT Plus (8.0) · Vision Rt, Ltd.510(k) · 2026-03-18
Halcyon, Ethos Radiotherapy System (5.0) · Varian Medical Systems, Inc.510(k) · 2026-01-21
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) · Elekta Solutions AB510(k) · 2026-01-15
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface · Brainlab SE510(k) · 2026-01-14
ChartCheck (RADCH V1.6) · Radformation, Inc.510(k) · 2026-01-05
IDENTIFY (5.0) · Varian Medical Systems, Inc.510(k) · 2025-12-16
ZAP-X Radiosurgery System (ZAP-X) · Zap Surgical Systems, Inc.510(k) · 2025-11-03
AccuCheck · Manteia Technologies Co., Ltd.510(k) · 2025-10-24
MOSkin Radiation Measurement System · Electrogenics Labs, Ltd.510(k) · 2025-10-17
TrueBeam, TrueBeam STX, Edge and VitalBeam · Varian Medical Systems, Inc.510(k) · 2025-10-07
AquaCast Mask · Blessing Cathay Corporation510(k) · 2025-09-03
Cranial 4Pi Immobilization · Brainlab AG510(k) · 2025-06-23
MapRT · Vision Rt, Ltd.510(k) · 2025-05-19
Mobius3D (4.1) · Varian Medical Systems510(k) · 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 · Macromedics BV510(k) · 2025-03-19
Klarity SGRT System (ARSG-E1A, ARSG-E3A) · Klarity Medical & Equipment (GZ) Co., Ltd.510(k) · 2025-03-18
Identify (4.0) · Varian Medical Systems, Inc.510(k) · 2025-02-07
ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface · Brainlab AG510(k) · 2024-07-24
BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) · Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla510(k) · 2024-05-31
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) · Varian Medical Systems, Inc.510(k) · 2024-04-30
VenusX · Linatech, LLC510(k) · 2024-04-12
LUNA 3D · Lap GmbH Laser Applikationen510(k) · 2024-03-29
AlignRT Plus · Vision Rt, Ltd.510(k) · 2024-03-29
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.