IYE
AlignRT Plus
- Advisory panel
- Radiology
- Total cleared
- 730
Adverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code IYE
1–100 of 730- K253962 — ClearCheck (RADCC V2.7)
- K253012 — AlignRT Plus (8.0)
- K252977 — Halcyon, Ethos Radiotherapy System (5.0)
- K252188 — EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
- K254010 — ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
- K252988 — ChartCheck (RADCH V1.6)
- K252919 — IDENTIFY (5.0)
- K250392 — ZAP-X Radiosurgery System (ZAP-X)
- K250696 — AccuCheck
- K250911 — MOSkin Radiation Measurement System
- K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam
- K252174 — AquaCast Mask
- K243142 — Cranial 4Pi Immobilization
- K243301 — MapRT
- K250099 — Mobius3D (4.1)
- 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
- K241937 — Klarity SGRT System (ARSG-E1A, ARSG-E3A)
- K242957 — Identify (4.0)
- K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
- K232738 — BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
- K232923 — Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
- K232489 — VenusX
- K232031 — LUNA 3D
- K233622 — AlignRT Plus
- K231573 — ThinkQA (Edition 2)
- K223234 — Delta4 Insight
- K231273 — ArcherQA (V1.0)
- K232293 — kallisio stentra oral stent
- K232870 — TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)
- K231852 — BinkieRT
- K232113 — Halcyon, Ethos Radiotherapy System
- K231317 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K230576 — IDENTIFY
- K223834 — AccuCheck
- K223159 — Radixact Treatment Delivery System
- K231185 — MapRT
- K222762 — SIDDHARTH-II;IMPACT
- K223839 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K231052 — ExacTrac Dynamic 1.1.2
- K230699 — ARIA Radiation Therapy Management (v18.0)
- K230312 — Iris AirShuttle
- K223209 — Elekta Unity
- K223229 — MOSAIQ® OIS (Oncology Information System)
- K222977 — DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip
- K222941 — Halcyon, Ethos Radiotherapy System
- K220539 — Klarity SRS Baseplate, Klarity Promise Baseplate
- K220583 — ClearCheck Model RADCC V2
- K213439 — FlexBoardTM, EagleBoardTM, BreastBoard SXTM
- K221408 — ARIA Radiation Therapy Management (v16.1 MR3)
- K221448 — ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
- K213977 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K213137 — INTDose
- K212909 — VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
- K213526 — Aurora-RT
- K220338 — ExacTrac Dynamic
- K213370 — VERIQA
- K213053 — Gold Anchor
- K212958 — MRIdian Linac System
- K212583 — AlignRT Plus
- K210921 — TaiChiB
- K212114 — Elekta Unity
- K212794 — Accuray Precision Treatment Planning System
- K210894 — SIDDHARTH-II; IMPACT
- K211760 — Panther OIS
- K212606 — BeamSite
- K203722 — RayPilot System
- K212294 — Ethos Treatment Management, Ethos Treatment Planning
- K211663 — Zap-X Radiosurgical System
- K211939 — ExacTrac Dynamic
- K210500 — Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
- K211590 — Fiducial Marker
- K211001 — C-Qual M Breastboard; Monarch Overhead Arm Positioner
- K202747 — Klarity Bolus
- K210835 — Identify
- K203387 — AlignRT Plus
- K203669 — Mobius3D
- K202412 — ClearRT Helical kVCT for the Radixact Treatment Delivery System
- K203172 — MOSAIQ Oncology Information System
- K200940 — BeamSite
- K203173 — ExacTrac Dynamic
- K202050 — Cranial 4Pi Immobilization
- K202068 — The AIO Solution 3.0
- K193207 — TaiChiA
- K201276 — ExacTrac Dynamic
- K200652 — Lollipop BiteBlock
- K201119 — ChartCheck
- K201117 — Gold Anchor
- K200907 — Thales 3D Mr Scanner
- K200435 — Catalyst+, Catalyst+ HD
- K192405 — Image Guidance System for Radiotherapy
- K200600 — Sentinel
- K190978 — RefleXion Medical Radiotherapy System
- K193243 — Alta Multipurpose Device
- K191646 — Beamscan MR
- K192377 — Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
- K193431 — AlignRT Plus
- K192196 — Medical Radiation Dosimetry System microSTARii
- K192482 — Elekta Unity
- K192242 — Synergy Platform, Synergy, Infinity, VersaHD
- K192968 — IDENTIFY
Data sourced from openFDA. This site is unofficial and independent of the FDA.