FDA.reportPublic FDA data

All-in-One Clinic Viewer

Primary DI
00863157000350
Brand
All-in-One Clinic Viewer
Company
SURGICAL THEATER LLC
Model
All-in-One
Device description
SuRgical Planner (SRP) Clinic Viewer Desktop
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123023000SURGERY REHEARSAL PLATFORMSurgical Theater, LLC2013-02-08LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863157000350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863157000350008631570003508631570003500863157000350

GMDN Terms#

Term, Definition table
TermDefinition
Surgical simulation systemA mobile computerized assembly of mains electricity (AC-powered) devices intended to collect and manipulate medical imaging [e.g., computed tomography (CT), magnetic resonance imaging (MRI)] data to create a patient-specific, virtual, three-dimensional (3-D), interactive model to enable a surgeon to simulate, rehearse, and plan a surgical procedure (e.g., cranial) prior to surgery. It includes dedicated software, and dedicated and/or off-the-shelf hardware such as a cart, a personal computer (PC), monitors, 3-D glasses, and a controller to simulate surgical devices and perform measurements. It is capable of collecting patient demographics, which may be anonymised.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
216-452-2177information@surgicaltheater.net

Regulatory Flags#

DUNS number
071341647
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863157000336SRPSRP2016-09-23
00863157000305SNAP ORSNAP2016-09-23
00860003884126SpineAR SNAPSpineAR2023-06-23
00860003884102SyncAR SNAPSyncAR2020-06-01
00860003884119SRP BrainStormBrainStorm2020-12-08
00863157000367SNAP Mini DesktopVR MSNAP2017-01-04
00863157000374SNAP Patient EngagementPE SNAP2017-03-27
00863157000312SNAP DesktopVR SNAP2016-09-23
00863157000329Endo SNAPEndo SNAP2016-09-13
00863157000343Notebook Clinic ViewerNotebook2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26