10/21/2025
K231897
NeuroAlign software
Medivis, Inc.
Neurology
HAW
10/16/2025
K252476
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
Brainlab AG
Radiology
LLZ
10/03/2025
K251639
xvision Spine system
Augmedics, Ltd.
Neurology
SBF
09/29/2025
K252054
SpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.
Neurology
SBF
09/10/2025
K252530
OptiVu Shoulder
MR Surgical Solutions, LLC
Neurology
SBF
09/04/2025
K251737
NextAR(TM) Shoulder Platform
Medacta International S.A.
Neurology
SBF
08/25/2025
K243709
NeuroEars-Anna
NeuroEars Inc.
Neurology
GWN
08/13/2025
K251519
RelieVRx (Pico G3)
AppliedVR
Neurology
QRA
08/08/2025
K252170
OptiVu Shoulder
MR Surgical Solutions, LLC
Neurology
SBF
07/31/2025
K250477
NextAR(TM) Spine
Medacta International S.A.
Neurology
SBF
07/11/2025
K241179
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
VivaQuant, Inc.
Cardiovascular
QYX
07/09/2025
K250108
OptiVu Shoulder
MR Surgical Solutions, LLC
Neurology
SBF
07/08/2025
K241525
ExcelsiusXR
Globus Medical, Inc.
Neurology
SBF
06/27/2025
K243077
Affirm 800
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
Radiology
IZI
06/23/2025
K250143
Digital Prism Correction Feature (DPCF)
Apple Inc.
Ophthalmic
SCW
06/20/2025
K243053
Navient Image Guided Navigation System (ENT) (955-NC-NC)
Claronav
Neurology
PGW
05/16/2025
K242569
Mixed Reality Spine Navigation
Brainlab AG
Neurology
SBF
05/02/2025
K243069
LUMYS (V1)
INTRADYS
Radiology
LLZ
04/09/2025
K243819
Luminopia
Luminopia, Inc.
Ophthalmic
QQU
03/21/2025
K243980
ARVIS Surgical Navigation System
Kico Knee Innovation Company Pty Limited
Neurology
SBF
03/20/2025
K243975
Knee+
Pixee Medical
Neurology
SBF
03/13/2025
K250255
xvision Spine system
Augmedics Ltd.
Neurology
SBF
01/14/2025
K242205
SpectoMed (v1.0)
Specto Medical
Radiology
LLZ
01/13/2025
K243950
ARVIS® Shoulder
Kico Knee Innovation Company Pty Ltd
Neurology
SBF
12/24/2024
K243623
SpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.
Neurology
SBF
12/04/2024
K243417
RelieVRx
AppliedVR
Neurology
QRA
10/30/2024
K242271
Caduceus S
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
Neurology
SBF
10/21/2024
K242058
Digital Prism Correction Feature (DPCF)
Apple Inc.
Ophthalmic
SCW
10/16/2024
K241481
xvision Spine System
Augmedics Ltd.
Neurology
SBF
09/10/2024
K240094
LumiNE US; Lumi
Augmedit B.V.
Radiology
QIH
08/19/2024
K241870
OnPoint Augmented Reality Spine System
OnPoint Surgical, Inc.
Neurology
SBF
08/08/2024
K233315
HipXpert and HipInsight System
Surgical Planning Associates, Inc
Neurology
OSF
07/26/2024
K233725
Spine Navigation System
Medivis, Inc.
Neurology
OLO
06/13/2024
K232930
VERVE
OculoMotor Technologies
Ophthalmic
SBN
05/21/2024
K232759
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
Brainlab AG
Radiology
LLZ
04/24/2024
K233172
NextAR Spine Platform
Medacta International S.A.
Neurology
OLO
03/25/2024
K240620
Cube Navigator
Medical Templates AG
Radiology
LLZ
03/08/2024
K230195
Neo ADVISE software
Comerge AG
Neurology
OLO
03/08/2024
K233899
Knee+
Pixee Medical
Neurology
OLO
02/01/2024
K232339
Augmented Reality Application
Sira Medical, Inc.
Radiology
LLZ
12/05/2023
K233568
Ceevra Reveal 3+
Ceevra, Inc.
Radiology
QIH
11/02/2023
K232176
STELLAR Knee
PolarisAR Inc.
Neurology
OLO
10/31/2023
K230814
VRNT
CognifiSense, Inc.
Neurology
QRA
10/29/2023
K232280
NextAR TSA Platform
Medacta International S.A.
Neurology
OLO
10/16/2023
K230249
Ikshana
ImmersiveTouch
Radiology
LLZ
09/25/2023
K230825
Smileyscope System (Therapy Mode)
Smileyscope Holding Inc.
Neurology
QRA
09/14/2023
K232189
OrionXR
Hoth Intelligence Inc.
Radiology
LLZ
09/08/2023
K231284
OnPoint Augmented Reality Spine System
OnPoint Surgical, Inc.
Neurology
OLO
08/31/2023
K231611
HOLO Portal Surgical Guidance System
Surgalign Spine Technologies
Neurology
OLO
07/21/2023
K223769
NextAR Spine Platform
Medacta International S.A.
Neurology
OLO
07/14/2023
K223290
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
SentiAR, Inc.
Radiology
LLZ
07/13/2023
K223125
XR90 (XR90-SYS)
MediView XR, Inc.
Radiology
LLZ
06/13/2023
K230567
OptiVu ROSA® MxR
Orthosoft Inc. (d/b/a Zimmer CAS)
Neurology
OLO
05/24/2023
K222035
Avatar Medical Software V1
Avatar Medical
Radiology
LLZ
05/01/2023
K221870
CarnaLife Holo
MedApp S.A.
Radiology
LLZ
04/25/2023
K222676
Ceevra Reveal 3
Ceevra, Inc.
Radiology
QIH
04/21/2023
K230789
Knee+
Pixee Medical
Neurology
OLO
02/24/2023
K222757
Clarus Viewer
Clarus Viewer Corporation
Radiology
LLZ
01/20/2023
K222510
Blueprint Mixed Reality system
Tornier SAS
Neurology
OLO
12/30/2022
K221796
Cyware 4H and Cysart 4H
Abys Medical
Radiology
LLZ
12/16/2022
K220554
Caduceus S
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
Neurology
OLO
11/25/2022
K213215
VSI HoloMedicine
ApoQlar GmbH
Radiology
LLZ
11/17/2022
K220905
xvision Spine System
Augmedics Ltd.
Neurology
OLO
11/04/2022
K221659
Luminopia One
Luminopia, Inc.
Ophthalmic
QQU
10/21/2022
K213128
IntraOp VSP Software Device
Xironetic, LLC
Radiology
LLZ
09/29/2022
K213034
SpineAR SNAP
Surgical Theater, Inc.
Neurology
OLO
09/01/2022
K220104
Knee+
Pixee Medical
Neurology
OLO
07/29/2022
K220733
OptiVu ROSA MxR
Orthosoft, Inc. (d/b/a Zimmer CAS)
Radiology
LLZ
07/12/2022
K221098
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
Stryker Corporation
Neurology
PGW
06/15/2022
K213684
SurgiCase Viewer
Materialise NV
Radiology
LLZ
05/27/2022
K220146
VisAR
Novarad Corporation
Neurology
OLO
03/10/2022
K213751
NextAR TKA Platform My Knee PPS
Medacta International S.A.
Neurology
OLO
01/14/2022
K211254
ARAI Surgical Navigation System
Surgalign Spine Technologies
Neurology
OLO
11/16/2021
DEN210014
EaseVRx
AppliedVR, Inc.
Neurology
QRA
11/10/2021
K210344
inVisionOS
PrecisionOS Technology Inc.
Radiology
LLZ
11/05/2021
K210859
NextAR Spine Platform
Medacta International, SA
Neurology
OLO
10/20/2021
DEN210005
Luminopia One
Luminopia, Inc.
Ophthalmic
QQU
10/02/2021
K202927
EYE-SYNC
SyncThink, Inc.
Neurology
QEA
09/29/2021
K210726
ImmersiveTouch
ImmersiveTouch, Inc.
Radiology
LLZ
07/19/2021
K211188
xvision Spine system (XVS)
Augmedics Ltd
Neurology
OLO
07/14/2021
K203115
ARVIS Surgical Navigation System
Insight Medical Systems Inc.
Neurology
OLO
05/14/2021
K210072
HOLOSCOPE-i
Real View Imaging Ltd.
Radiology
LLZ
05/12/2021
K210153
NextAR RSA Platform
Medacta International SA
Neurology
OLO
04/21/2021
K202750
Knee+
Pixee Medical
Neurology
OLO
01/28/2021
K200384
HipXpert 3D Display and Anchoring Application
Surgical Planning Associates, Inc
Neurology
OSF
10/27/2020
K202152
NextAR TKA Platform
Medacta International SA
Neurology
OLO
09/18/2020
K192890
SentEP
SentiAR, Inc
Radiology
LLZ
07/17/2020
K201465
SuRgical Planner (SRP) BrainStorm
Surgical Theater, Inc.
Radiology
LLZ
07/10/2020
K193559
NextAR TKA Platform
Medacta Inernational SA
Orthopedic
PBF
01/23/2020
K191014
Elements Viewer
Brainlab AG
Radiology
LLZ
12/20/2019
K190929
xvision Spine system (XVS)
Augmedics Ltd.
Neurology
OLO
11/29/2019
K192186
I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
Neurolign USA, LLC
Neurology
GWN
08/29/2019
K183489
D2P
3D Systems, Inc.
Radiology
LLZ
05/13/2019
K190764
SurgicalAR
MEDIVIS, Inc.
Radiology
LLZ
03/18/2019
K183296
REAL Immersive System
Penumbra, Inc.
Physical Medicine
ISD
02/22/2019
K182643
IRIS 1.0 System
Intuitive Surgical
Radiology
LLZ
02/14/2019
K190074
Presero 3D Scanning System
Certis Health
Radiology
LLZ
09/21/2018
K172418
OpenSight
Novarad Corporation
Radiology
LLZ
07/10/2018
K173274
Ceevra Reveal 2.0
Ceevra, Inc.
Radiology
LLZ
02/12/2018
K170793
SuRgical Planner (SRP)
Surgical Theater, LLC
Radiology
LLZ
08/03/2017
K171356
Clarity Reveal
Ceevra, Inc.
Radiology
LLZ
04/24/2017
K162748
MindMotionPRO
MindMaze SA
Physical Medicine
LXJ
03/03/2017
K170167
True 3D Viewer Software
EchoPixel Inc.
Radiology
LLZ
02/28/2017
K163245
Virtual Occupational Therapy Application (VOTA)
Barron Associates, Inc.
Physical Medicine
LXJ
06/28/2016
K160584
Surgical Navigation Advanced Platform (SNAP)
SURGICAL THEATER, LLC
Radiology
LLZ
02/12/2016
K153004
Clear Guide SCENERGY
CLEAR GUIDE MEDICAL
Radiology
JAK
02/05/2016
K151955
YuGo System
BIOGAMING LTD.
Physical Medicine
LXJ
01/29/2016
K152915
EYE-SYNC
SyncThink, Inc.
Neurology
GWN
01/21/2015
K142107
ECHO TRUE 3D VIEWER
ECHO PIXEL INC.
Radiology
LLZ