Regulatory

Every AR/VR device the FDA has authorized.

120 devices from 70 companies, copied from the FDA's own list and checked for changes every day. Each row links to its FDA database record.

This is the regulator's list, shown as published. FDA authorization means a device may be marketed in the US for its stated use; it is not evidence of clinical effectiveness and not an AVRMD endorsement. Source: FDA, Augmented Reality and Virtual Reality Medical Devices (FDA page updated 2026-09-04).

46 devices
  1. 2026-05-27Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)RadiologyK254265
  2. 2026-03-30Avatar Medical VisionAvatar MedicalRadiologyK253950
  3. 2026-03-27ARTICOR plannerArtiness S.R.LRadiologyK252195
  4. 2026-02-23SKIA-Head (Model: SKIA-ST00)Skia, Inc.RadiologyK253486
  5. 2026-02-06LAIA XRAugmented Reality Software S.L.RadiologyK251577
  6. 2026-01-29Surgical Reality ViewerMedicalvr B.V.RadiologyK252091
  7. 2025-10-16Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AGRadiologyK252476
  8. 2025-06-27Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)RadiologyK243077
  9. 2025-05-02LUMYS (V1)INTRADYSRadiologyK243069
  10. 2025-01-14SpectoMed (v1.0)Specto MedicalRadiologyK242205
  11. 2024-09-10LumiNE US; LumiAugmedit B.V.RadiologyK240094
  12. 2024-05-21Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AGRadiologyK232759
  13. 2024-03-25Cube NavigatorMedical Templates AGRadiologyK240620
  14. 2024-02-01Augmented Reality ApplicationSira Medical, Inc.RadiologyK232339
  15. 2023-12-05Ceevra Reveal 3+Ceevra, Inc.RadiologyK233568
  16. 2023-10-16IkshanaImmersiveTouchRadiologyK230249
  17. 2023-09-14OrionXRHoth Intelligence Inc.RadiologyK232189
  18. 2023-07-14CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)SentiAR, Inc.AVRMD record: SentiARRadiologyK223290
  19. 2023-07-13XR90 (XR90-SYS)MediView XR, Inc.RadiologyK223125
  20. 2023-05-24Avatar Medical Software V1Avatar MedicalRadiologyK222035
  21. 2023-05-01CarnaLife HoloMedApp S.A.RadiologyK221870
  22. 2023-04-25Ceevra Reveal 3Ceevra, Inc.RadiologyK222676
  23. 2023-02-24Clarus ViewerClarus Viewer CorporationRadiologyK222757
  24. 2022-12-30Cyware 4H and Cysart 4HAbys MedicalRadiologyK221796
  25. 2022-11-25VSI HoloMedicineApoQlar GmbHRadiologyK213215
  26. 2022-10-21IntraOp VSP Software DeviceXironetic, LLCRadiologyK213128
  27. 2022-07-29OptiVu ROSA MxROrthosoft, Inc. (d/b/a Zimmer CAS)RadiologyK220733
  28. 2022-06-15SurgiCase ViewerMaterialise NVRadiologyK213684
  29. 2021-11-10inVisionOSPrecisionOS Technology Inc.AVRMD record: PrecisionOSRadiologyK210344
  30. 2021-09-29ImmersiveTouchImmersiveTouch, Inc.RadiologyK210726
  31. 2021-05-14HOLOSCOPE-iReal View Imaging Ltd.RadiologyK210072
  32. 2020-09-18SentEPSentiAR, IncAVRMD record: SentiARRadiologyK192890
  33. 2020-07-17SuRgical Planner (SRP) BrainStormSurgical Theater, Inc.AVRMD record: Surgical Theater XRRadiologyK201465
  34. 2020-01-23Elements ViewerBrainlab AGRadiologyK191014
  35. 2019-08-29D2P3D Systems, Inc.RadiologyK183489
  36. 2019-05-13SurgicalARMEDIVIS, Inc.RadiologyK190764
  37. 2019-02-22IRIS 1.0 SystemIntuitive SurgicalRadiologyK182643
  38. 2019-02-14Presero 3D Scanning SystemCertis HealthRadiologyK190074
  39. 2018-09-21OpenSightNovarad CorporationRadiologyK172418
  40. 2018-07-10Ceevra Reveal 2.0Ceevra, Inc.RadiologyK173274
  41. 2018-02-12SuRgical Planner (SRP)Surgical Theater, LLCAVRMD record: Surgical Theater XRRadiologyK170793
  42. 2017-08-03Clarity RevealCeevra, Inc.RadiologyK171356
  43. 2017-03-03True 3D Viewer SoftwareEchoPixel Inc.RadiologyK170167
  44. 2016-06-28Surgical Navigation Advanced Platform (SNAP)SURGICAL THEATER, LLCAVRMD record: Surgical Theater XRRadiologyK160584
  45. 2016-02-12Clear Guide SCENERGYCLEAR GUIDE MEDICALRadiologyK153004
  46. 2015-01-21ECHO TRUE 3D VIEWERECHO PIXEL INC.RadiologyK142107