FDA.reportPublic FDA data

Stereotactic system application software

Definition
An application software program intended to facilitate stereotactic treatment procedures (surgery or radiosurgery) by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, real-time surgical navigation and/or patient/procedure data management, image processing/transfer, and quality assurance. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.
GUDID devices
38
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07340048311878Leksell GammaPlanElekta Instrument AB15512872020-06-13
07340201503898Leksell GammaPlanElekta Solutions AB15777562026-02-04
04056481145873Image FusionBrainlab SE5.02025-06-26
04056481145880ContouringBrainlab SE5.02025-06-26
04056481145897FibertrackingBrainlab SE3.02025-06-26
M9461099390THINK Case ManagerTHINK SURGICAL, INC.1099392025-04-24
04056481143916Spine PlanningBrainlab SE2.02024-11-05
03770021895035OptimMRI (v2)REBRAINv2.0.12024-10-22
07340201502136Leksell GammaPlanElekta Solutions AB15677142024-02-14
03770021895011OptimMRIREBRAINv1.2.02023-12-08
M9461090000TPLAN® Planning StationTHINK SURGICAL, INC.1090002023-08-28
04056481143824Brainlab Elements BOLD MRI MappingBrainlab SE1.02023-07-20
04056481143992Brainlab Elements Image FusionBrainlab SE4.52023-07-20
04056481144623Brainlab Elements ContouringBrainlab SE4.52023-07-20
04056481143015Brainlab Elements ContouringBrainlab SE4.02023-06-21
04056481142674Brainlab Elements - Trajectory PlanningBrainlab SE2.62023-04-24
07613327513950ScopisStryker Leibinger GmbH & Co. KG8000-021-0052022-10-20
07613327513943ScopisStryker Leibinger GmbH & Co. KG8000-021-0012022-10-19
07613327514179ScopisStryker Leibinger GmbH & Co. KG8000-021-0022022-10-19
00860001580907SIS SystemSurgical Information Sciences Inc.6.X.X, 7.X.X2021-06-03
00884838104570ClarifEyePhilips Medical Systems Nederland B.V.ClarifEye - 12021-03-12
B057U40030NOVA ARScopis GmbH2.6.152018-01-04
B057U4003260160NOVA ARScopis GmbH2.6.162018-02-20
B057U4003260170NOVA ARScopis GmbH2.6.172018-04-20
B057U40140NOVA BasicScopis GmbH2.6.82018-01-04
B169SOFTWARE0Compass InternationalCompass InternationalSOFTWARE2016-08-26
B365501350PinPoint Autoregistration SoftwareAktina Corp.50-1352016-09-24
07340048311229Leksell GammaPlanElekta Instrument AB15296042018-04-18
07340048311236Leksell GammaPlanElekta Instrument AB15299802018-05-10
07613327413199Scopis ENTStryker Leibinger GmbH & Co. KG8000-020-0022018-08-08
07613327413243Scopis ENTStryker Leibinger GmbH & Co. KG8000-020-0012018-08-08
00850002615012GammaPod™ Treatment Control SystemXCISION MEDICAL SYSTEMS, LLCModel A2019-03-01
00850002615029GammaPod™ Treatment Planning SystemXCISION MEDICAL SYSTEMS, LLCModel A2019-03-01
00884838066991InvivoPhilips DS North America LLC7840112016-09-23
00884838081543InvivoPhilips DS North America LLC7840122016-09-23
00884838081550InvivoPhilips DS North America LLC7840152016-09-23
00884838083592InvivoPhilips DS North America LLC7840012016-09-23
00643169705432StealthConnectMEDTRONIC NAVIGATION, INC.97356962018-04-15