FDA.reportPublic FDA data

Robotic surgical system application software

Definition
An individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical system typically used in computer assisted surgery (CAS) during orthopaedic procedures so that this can function according to its intended purpose. This program can be permanently installed or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
GUDID devices
43
Last updated
2026-01-15 17:33:29

Related Product Codes

CodeDeviceSpecialtyClassDevices
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat216
JAKSystem, X-Ray, Tomography, ComputedRadiology212
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology18
QQHPowered Insertion System For A Cochlear Implant Electrode ArrayEar, Nose, Throat26
LLZSystem, Image Processing, RadiologicalRadiology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00198506087424ELMED INCORPORATEDELMED INCORPORATED31-22352026-01-07
10810068811497Monarch™ Tower Software v4.1.1AURIS HEALTH, INC.Version 4.1.12025-06-04
10810068811503Monarch™ Cart Software v4.1.1AURIS HEALTH, INC.Version 4.1.12025-06-04
10810068811510Monarch™ Laptop P17 Software v4.1.1AURIS HEALTH, INC.Version 4.1.12025-06-04
10810068811527Monarch™ Laptop P16 Software v4.1.1AURIS HEALTH, INC.Version 4.1.12025-06-04
10810068810582Monarch™ Tower Software v4.1.0AURIS HEALTH, INC.Version 4.1.02025-03-03
10810068810599Monarch™ Cart Software v4.1.0AURIS HEALTH, INC.Version 4.1.02025-03-03
10810068810605Monarch™ Laptop P17 Software v4.1.0AURIS HEALTH, INC.Version 4.1.02025-03-03
10810068810612Monarch™ Laptop P16 Software v4.1.0AURIS HEALTH, INC.Version 4.1.02025-03-03
00850002960006iotaSOFT Insertion SystemIotamotion, Inc.IM-002024-09-20
00850002960020iotaSOFT Insertion SystemIotamotion, Inc.IM-022024-09-20
00850002960037iotaSOFT Insertion SystemIotamotion, Inc.IM-032024-09-20
00850002960044iotaSOFT Insertion SystemIotamotion, Inc.IM-042024-09-20
00850002960051iotaSOFT Insertion SystemIotamotion, Inc.IM-012024-09-20
00850002960068iotaSOFT Insertion SystemIotamotion, Inc.IM-052024-09-20
00198506058103ELMEDELMED INCORPORATED83-31000-CC2024-06-18
00198506001642ELMEDELMED INCORPORATEDST3107035352024-04-24
00198506001659ELMEDELMED INCORPORATEDST3107039392024-04-24
00842180191426ELMEDELMED INCORPORATEDST13CG08232024-04-10
10810068810766Monarch™ Software Tower v2.2.5AURIS HEALTH, INC.Version 2.2.52024-02-16
10810068810773Monarch™ Software Cart v2.2.5AURIS HEALTH, INC.Version 2.2.52024-02-16
10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5AURIS HEALTH, INC.Version 2.2.52024-02-16
10810068810797Monarch™ Laptop P17/P73 Linux USB Image v2.2.5AURIS HEALTH, INC.Version 2.2.52024-02-16
00842180177390ELMEDELMED INCORPORATED13-CG08232023-09-07
00842180172760ELMEDELMED INCORPORATED31070-35 352023-07-10
00842180172777ELMEDELMED INCORPORATED31070-39 392023-07-10
10810068810476Monarch™ Software Tower v2.2.4AURIS HEALTH, INC.Version 2.2.42023-02-03
10810068810483Monarch™ Software Cart v2.2.4AURIS HEALTH, INC.Version 2.2.42023-02-03
10810068810490Monarch™ Laptop P70 Linux USB Image v2.2.4AURIS HEALTH, INC.Version 2.2.42023-02-03
10810068810506Monarch™ Laptop P17/P73 Linux USB Image v2.2.4AURIS HEALTH, INC.Version 2.2.42023-02-03
B634SW0121880201060Monarch Software Tower v2.1.6AURIS HEALTH, INC.Version 2.1.62020-03-05
B634SW0121890201060Monarch Software Cart v2.1.6AURIS HEALTH, INC.Version 2.1.62020-03-05
B634SW0121920202000Monarch Software Tower v2.2.1AURIS HEALTH, INC.Version 2.2.12020-03-05
B634SW0121930202000Monarch Software Cart v2.2.1AURIS HEALTH, INC.Version 2.2.12020-03-05
B634SW0032740201050Monarch™ Software Tower v2.1.5AURIS HEALTH, INC.Version 2.1.52019-09-10
B634SW0032750201050Monarch™ Software Cart v2.1.5AURIS HEALTH, INC.Version 2.1.52019-09-10
B634SW0032740201040Monarch™ Software Tower v2.1.4AURIS HEALTH, INC.Version 2.1.42019-05-10
B634SW0032750201040Monarch™ Software Cart v2.1.4AURIS HEALTH, INC.Version 2.1.42019-05-10
B634SW0032740201020Monarch™ Software Tower v2.1.2AURIS HEALTH, INC.Version 2.1.22018-06-08
B634SW0032740201030Monarch™ Software Tower v2.1.3AURIS HEALTH, INC.Version 2.1.32018-10-15
B634SW0032750201020Monarch™ Software Cart v2.1.2AURIS HEALTH, INC.Version 2.1.22018-06-08
B634SW0032750201030Monarch™ Software Cart v2.1.3AURIS HEALTH, INC.Version 2.1.32018-10-15