IYE · Accelerator, Linear, Medical
Radiology · 21 CFR 892.5050 · Class 2
Overview
| Product Code | IYE |
|---|---|
| Device Name | Accelerator, Linear, Medical |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
Classification Rationale
Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 731)
Showing 20 most recent of 731 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252258 | VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | Apr 15, 2026 | SESE |
| K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | Apr 3, 2026 | SESE |
| K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | Mar 18, 2026 | SESE |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | Jan 21, 2026 | SESE |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB | Jan 15, 2026 | SESE |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | Jan 14, 2026 | SESE |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | Jan 5, 2026 | SESE |
| K252919 | IDENTIFY (5.0) | Varian Medical Systems, Inc. | Dec 16, 2025 | SESE |
| K250392 | ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. | Nov 3, 2025 | SESE |
| K250696 | AccuCheck | Manteia Technologies Co., Ltd. | Oct 24, 2025 | SESE |
| K250911 | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. | Oct 17, 2025 | SESE |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. | Oct 7, 2025 | SESE |
| K252174 | AquaCast Mask | Blessing Cathay Corporation | Sep 3, 2025 | SESE |
| K243142 | Cranial 4Pi Immobilization | Brainlab AG | Jun 23, 2025 | SESE |
| K243301 | MapRT | Vision Rt, Ltd. | May 19, 2025 | SESE |
| K250099 | Mobius3D (4.1) | Varian Medical Systems | May 16, 2025 | SESE |
| K250429 | 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 BV | Mar 19, 2025 | SESE |
| K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. | Mar 18, 2025 | SESE |
| K242957 | Identify (4.0) | Varian Medical Systems, Inc. | Feb 7, 2025 | SESE |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Brainlab AG | Jul 24, 2024 | SESE |
Top Applicants
- Varian Medical Systems, Inc. — 69 clearances
- Varian Assoc., Inc. — 27 clearances
- Brainlab AG — 21 clearances
- Medtec, Inc. — 20 clearances
- Siemens Medical Solutions USA, Inc. — 18 clearances
