FDA Product Code
FDA Product Code IYE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5050
510(k) Clearances — 738 records · page 2 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193243 | Alta Multipurpose Device | Qfix | 2020-02-28 | Traditional | PDF ↗ |
| K191646 | Beamscan MR | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2020-02-21 | Traditional | PDF ↗ |
| K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | Varian Medical Systems, Inc. | 2020-02-10 | Traditional | PDF ↗ |
| K193431 | AlignRT Plus | Vision Rt, Ltd. | 2020-01-03 | Special | PDF ↗ |
| K192196 | Medical Radiation Dosimetry System microSTARii | Landauer | 2019-12-27 | Traditional | PDF ↗ |
| K192482 | Elekta Unity | Elekta Limited | 2019-12-05 | Traditional | PDF ↗ |
| K192242 | Synergy Platform, Synergy, Infinity, VersaHD | Elekta Limited | 2019-11-22 | Traditional | PDF ↗ |
| K192968 | IDENTIFY | Varian Medical Systems, Inc. | 2019-11-12 | Special | PDF ↗ |
| K191944 | MU2net | Dosisoft | 2019-10-24 | Traditional | PDF ↗ |
| K192424 | Mobius3D | Varian Medical Systems, Inc. | 2019-10-03 | Special | PDF ↗ |
| K192102 | Thermoplastic Masks | Aktina Medical Corporation | 2019-09-25 | Traditional | PDF ↗ |
| K191158 | The AIO Solution | Orfit Industries NV | 2019-08-06 | Traditional | PDF ↗ |
| K191267 | ImagingRing System on Rails | Medphoton GmbH | 2019-08-01 | Traditional | PDF ↗ |
| K191761 | Mobius3D | Varian Medical Systems, Inc. | 2019-07-31 | Special | PDF ↗ |
| K191797 | BiomarC Fiducial Marker | Carbon Medical Technologies | 2019-07-29 | Special | PDF ↗ |
| K190137 | Identify | Varian Medical Systems, Inc. | 2019-07-10 | Traditional | PDF ↗ |
| K182374 | LIAC S | Sit Sordina Iort Technologies Spa | 2019-05-22 | Traditional | PDF ↗ |
| K190894 | TOTIM Patient Cushion Immobilization System | Essebi Medical Srl | 2019-04-30 | Traditional | PDF ↗ |
| K183606 | Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) | Scandidos AB | 2019-04-08 | Traditional | PDF ↗ |
| K190155 | FibermarX Radiopaque Tissue Marker | Viscus Biologics, LLC | 2019-02-27 | Traditional | PDF ↗ |
| K183374 | GrayDuck Stent | Poll Medical, LLC | 2019-02-26 | Traditional | PDF ↗ |
| K183698 | Zap-X Radiosurgery System | Zap Surgical Systems | 2019-02-25 | Traditional | PDF ↗ |
| K181989 | MRIdian Linac System | Viewray, Incorporated | 2019-02-20 | Traditional | PDF ↗ |
| K182076 | Elekta Unity | Elekta Limited | 2018-12-04 | Traditional | PDF ↗ |
| K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | 2018-12-04 | Traditional | PDF ↗ |
| K182687 | Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System | Accuray Incorporated | 2018-11-23 | Traditional | PDF ↗ |
| K182189 | Encompass SRS Headframe ; Encompass MR SRS Headframe | Qfix | 2018-10-04 | Special | PDF ↗ |
| K182050 | Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch | Siemens Medical Solutions USA, Inc. | 2018-10-03 | Traditional | PDF ↗ |
| K173926 | DORADOnova MR3T | Lap GmbH Laser Applikationen | 2018-09-14 | Traditional | PDF ↗ |
| K182079 | Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask | Medtec Inc. Dba Civco Medical Solutions | 2018-09-07 | Traditional | PDF ↗ |
| K182138 | Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD | Eleckta Limited | 2018-09-05 | Traditional | PDF ↗ |
| K173848 | Model WP-3840 and WP-3040 | Cnmc Co., Inc. | 2018-08-07 | Traditional | PDF ↗ |
| K181218 | AlignRT Plus | Vision Rt, Ltd. | 2018-08-07 | Traditional | PDF ↗ |
| K180027 | ACCUSYTE 3D Fiducial Marker | Radiation Products, LLC | 2018-07-18 | Traditional | PDF ↗ |
| K180697 | Pseudo-Patient | Rtsafe, Inc. | 2018-07-10 | Traditional | PDF ↗ |
| K180021 | Proton Positioing and Immobilization Devices | Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap | 2018-06-29 | Traditional | PDF ↗ |
| K181404 | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator | Varian Medical Systems, Inc. | 2018-06-28 | Special | PDF ↗ |
| K172961 | LIAC HWL | Sit Sordina Iort Technologies Spa | 2018-06-11 | Traditional | PDF ↗ |
| K181032 | Halcyon | Varian Medical Systems, Inc. | 2018-05-09 | Special | PDF ↗ |
| K170570 | Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung | Varian Medical Systems, Inc. | 2018-04-06 | Traditional | PDF ↗ |
| K180595 | SciMoCa | Radialogica, LLC | 2018-04-04 | Traditional | PDF ↗ |
| K180586 | Varian Head Frame | Varian Medical Systems, Inc. | 2018-04-02 | Special | PDF ↗ |
| K180106 | ThinkQA | Dosisoft | 2018-03-13 | Traditional | PDF ↗ |
| K173838 | ARIA Radiation Therapy Management | Varian Medical Systems, Inc. | 2018-01-17 | Special | PDF ↗ |
| K173251 | LumiCoil Platinum Fiducial Marker | Boston Scientific Corporation | 2017-12-19 | Traditional | PDF ↗ |
| K171352 | EZFluence | Radformation, Inc. | 2017-12-01 | Traditional | PDF ↗ |
| K171350 | Collision Check | Radformation, Inc. | 2017-11-29 | Traditional | PDF ↗ |
| K171467 | BioZorb Marker GOLD / LP Marker GOLD | Focal Therapeutics | 2017-11-09 | Traditional | PDF ↗ |
| K172534 | LINACwatch, LinacView | Qualiformed Sarl | 2017-10-27 | Traditional | PDF ↗ |
| K170345 | SOFTDISO | Best Nomos | 2017-10-27 | Traditional | PDF ↗ |
| K170307 | SunCHECK | Sun Nuclear Corporation | 2017-10-25 | Traditional | PDF ↗ |
| K160405 | OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2017-10-20 | Traditional | PDF ↗ |
| K171804 | Zap-X Radiosurgery System | Zap Surgical Systems | 2017-09-21 | Traditional | PDF ↗ |
| K172013 | VitalBeam | Varian Medical Systems, Inc. | 2017-07-28 | Special | PDF ↗ |
| K171837 | TomoTherapy Treatment Delivery System with iDMS | Accuray Incorporated | 2017-07-25 | Traditional | PDF ↗ |
| K171734 | HP PRO Positioning Device | Orfit Industries NV | 2017-07-25 | Traditional | PDF ↗ |
| K171733 | TrueBeam, TrueBeam STx, Edge | Varian Medical Systems, Inc. | 2017-07-12 | Special | PDF ↗ |
| K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories | Qfix | 2017-07-11 | Traditional | PDF ↗ |
| K170817 | Halcyon | Varian Medical Systems, Inc. | 2017-06-27 | Traditional | PDF ↗ |
| K171086 | Accuray Precision Treatment Planning System | Accuray Incorporated | 2017-06-08 | Traditional | PDF ↗ |
| K170751 | MRIdian Linac System with 138-leaf Collimator | Viewray, Incorporated | 2017-06-07 | Traditional | PDF ↗ |
| K161807 | BEAMSCAN | Ptw-Freiburg Physikalisch Technische-Werksraetten | 2017-05-19 | Traditional | PDF ↗ |
| K161724 | Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) | Radiomed Corporation | 2017-04-28 | Traditional | PDF ↗ |
| K170788 | CyberKnife Treatment Delivery System | Accuray Incorportaed | 2017-04-11 | Traditional | PDF ↗ |
| K170058 | TheraView TBI | Cablon Medical B.V. | 2017-03-03 | Special | PDF ↗ |
| K162393 | The ViewRay (MRIdian) Linac System | Viewray, Incorporated | 2017-02-24 | Traditional | PDF ↗ |
| K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017-01-19 | Traditional | PDF ↗ |
| K162476 | Varian High Energy Linear Accelerator | Varian Medical Systems, Inc. | 2016-12-12 | Special | PDF ↗ |
| K161400 | ImagingRing System | Medphoton GmbH | 2016-12-08 | Traditional | PDF ↗ |
| K162468 | ClearCheck | Radformation | 2016-12-01 | Traditional | PDF ↗ |
| K162355 | Raycast MammoRx Carbon Fibre Breast Board | Orfit Industries NV | 2016-11-22 | Traditional | PDF ↗ |
| K162577 | Dosimetry Check Version 5 Release 1 | Math Resolutions, LLC | 2016-11-18 | Traditional | PDF ↗ |
| K162265 | CushionCast Moldable Cushions | Izi Medical Products, LLC | 2016-11-15 | Traditional | PDF ↗ |
| K162862 | Raycast High Precision Lung Board Solution | Orfit Industries NV | 2016-11-09 | Traditional | PDF ↗ |
| K162002 | Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay | Zdi, Solutions, LLC | 2016-11-01 | Traditional | PDF ↗ |
| K162629 | IQM Integral Quality Monitor (also IQM) | Irt Systems | 2016-10-20 | Traditional | PDF ↗ |
| K161984 | Interlocked Circular Small Field Collimators, Elekta Integrated | Aktina Medical Corporation | 2016-09-27 | Traditional | PDF ↗ |
| K161946 | DoseCHECK | Sun Nuclear Corporation | 2016-09-16 | Traditional | PDF ↗ |
| K161146 | Radixact Treatment Delivery System | Accuray Incorporated | 2016-06-24 | Traditional | PDF ↗ |
| K161144 | iDMS Data Management System | Accuray Incorporated | 2016-06-24 | Traditional | PDF ↗ |
| K160209 | Gold Anchor | Naslund Medical AB | 2016-06-21 | Traditional | PDF ↗ |
| K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution | Qfix | 2016-06-14 | Traditional | PDF ↗ |
| K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement | Medtec, Inc. D/B/A Civco Medical Solutions | 2016-05-25 | Traditional | PDF ↗ |
| K160057 | ArcCHECK-MR | Sun Nuclear Corporation | 2016-05-13 | Traditional | PDF ↗ |
| K153014 | Mobius3D | Mobius Medical Systems, LP | 2016-04-29 | Traditional | PDF ↗ |
| K153270 | TruGuard Custom Tongue and Jaw Positioner | Bionix Development Corp. | 2016-03-08 | Traditional | PDF ↗ |
| K152994 | Adaptivo | Aurora Technology Development, LLC | 2016-02-03 | Traditional | PDF ↗ |
| K151426 | ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ | Scandidos AB | 2016-01-29 | Traditional | PDF ↗ |
| K153011 | iViewDose R1.0 | Elekta Limited | 2015-12-11 | Traditional | PDF ↗ |
| K152321 | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening | Qfix | 2015-12-04 | Traditional | PDF ↗ |
| K152761 | Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) | Varian Medical Systems, Inc. | 2015-11-25 | Special | PDF ↗ |
| K142617 | ArcCHECK | Sun Nuclear Corporation | 2015-11-20 | Traditional | PDF ↗ |
| K151946 | Thermofit | Orfit Industries | 2015-11-09 | Traditional | PDF ↗ |
| K151882 | Varian Treatment (VTx) | Varian Medical Systems, Inc. | 2015-10-26 | Traditional | PDF ↗ |
| K152867 | MHI-TM2000 Linear Accelerator System, VERO, Imavis | Mitsubishi Heavy Industries, Ltd. | 2015-10-21 | Special | PDF ↗ |
| K143560 | CygneX I System | Accuthera, Inc. | 2015-10-05 | Traditional | PDF ↗ |
| K150382 | Radio Therapy Treatment Chair | Radiation Products Design, Inc. | 2015-09-16 | Traditional | PDF ↗ |
| K150265 | Model 206 Electrometer/Dosimeter | Cnmc Company Incorporated | 2015-09-03 | Traditional | PDF ↗ |
| K151180 | ScandiDos Delta4 Phantom+ | Scandidos AB | 2015-08-19 | Traditional | PDF ↗ |
| K150767 | EDOSE | Guangzhou Raydose Software Technology., LLC | 2015-08-17 | Traditional | PDF ↗ |
Product code IYE · Class II · Radiology. Data: openFDA.