Product code IYE— Radiology
AlignRT Plus
- Classification name
- Accelerator, Linear, Medical
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Total cleared
- 738
- First cleared
- Most recent
Clearances under product code IYE — page 3
201–300 of 738- K151207 — Proton Immobilization Solution
- K150873 — CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System
- K150848 — Dose Calculator
- K151097 — Active Breathing Coordinator
- K150706 — VitalBeam
- K142420 — Patient Positioning Devices
- K142294 — FlexiMarc Marker
- K143485 — iGuide 2.1
- K143224 — TrueBeam-TrueBeam STx-Edge
- K142560 — Varian Head Frame
- K142142 — QUALITY REPORTS
- K142431 — WaterProof PROFILER
- K142434 — ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
- K141855 — CLARITY
- K142268 — Varian Verification System (VVS)
- K141800 — PERFRACTION
- K140528 — TRUE BEAM, TRUE BEAM STX, EDGE
- K141572 — MOSAIQ ONCOLOGY INFORMATION SYSTEM
- K141230 — DOSELAB PRO
- K141787 — SAGITTILT
- K140823 — PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER
- K140660 — MOBIUS3D
- K133572 — ARIA RADIATION THERAPY MANAGEMENT
- K133227 — SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING
- K132908 — TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
- K132064 — BIOMARC FIDUCIAL MARKER
- K132935 — ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME
- K133240 — VARIAN MULTILEAF COLLIMATOR
- K132605 — DOSIMETRY CHECK VERSION 4 RELEASE 1
- K132124 — KLARITY VACUUM BAG, KLARITY MOLD CUSHION
- K132705 — UNIQUE
- K131807 — HIGH ENERGY LINEAR ACCELERATOR
- K131795 — NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
- K131965 — XVI R5.0
- K131862 — 3DVH
- K131466 — MAPCHECK2, ARCCHECK
- K131313 — ACTIVE BREATHING COORDINATOR
- K131704 — EPIDOSE
- K121284 — CHABNER XRT GARMENTS
- K130992 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
- K122888 — CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM
- K130678 — BIOMARC GOLD FIDUCIAL MARKER
- K123808 — AGILITY
- K123812 — COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV
- K123788 — INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)
- K123371 — ALIGNRT PLUS
- K122616 — PANTHER OIS/R & V MODEL VERSION 2.0
- K123291 — TRUEBEAM
- K123230 — MOSAIQ ONCOLOGY INFORMATION SYSTEM
- K121663 — CLARITY
- K123137 — CALYPSO SYSTEM
- K122137 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM
- K121657 — PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR
- K121845 — SDX SYSTEM
- K122450 — MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS
- K122451 — EXACTRAC VERO
- K121934 — TOMOTHERAPY TREATMENT SYSTEM
- K120789 — EXACTRAC X-RAY X-RAY
- K112692 — IDENTIFY
- K120668 — SENTINEL
- K121295 — ARTISTETM SOLUTION WITH SYS VCIO
- K121530 — BODYFIX SYSTEM
- K121328 — AGILITY
- K111862 — VIEWRAY SYSTEM
- K120335 — EMBRACE THERMOPLASTIC
- K112286 — NOVAC 11
- K110840 — LIAC
- K120233 — SYNCHRONY RESPIRATORY TRACKING SYSTEM
- K120067 — MOSAIQ ONCOLOGY INFORMATION SYSTEM
- K113276 — CATALYST
- K112841 — SURFACE BEACON TRANSPONDERS
- K111332 — CLARITY OBP SYSTEM
- K110971 — TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT
- K113758 — VOLUSON E6/E8/E8EXPERT/E10
- K112778 — SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING
- K112613 — INTEGRITY(TM)
- K112210 — FRAXION
- K112839 — VARIAN HIGH ENERGY LINEAR ACCELERATOR
- K112460 — MULTIPLE
- K111106 — TRUEBEAM
- K110772 — BIOMARC FIDUCIAL MARKER
- K103606 — ARTISTE SOLUTION WITH SYS_VB50 UPDATE
- K103616 — PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
- K100625 — REALEYE MODEL VCPS
- K103394 — BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
- K103193 — DOSEVIEW 3D
- K102765 — PRONEX
- K102237 — PVS MODEL 1.0
- K102650 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K102200 — INTEGRITY MODEL 1014284
- K102583 — MUCHECK, VERSION 9.0
- K102024 — RPM RESPIRATORY GATING SYSTEM
- K102671 — SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2
- K101992 — 3D SCANNER, MODEL 1230
- K101751 — VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
- K101503 — DUSIMETRY CHECK
- K100890 — VARIAN HIGH ENERGY LINEAR ACCELERATOR
- K093967 — VARIAN TREATMENT
- K100801 — PUMA MODEL VERSION 1.0
- K101131 — FIDUCIAL MARKERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.