FDA.reportPublic FDA data

CapSure Cloud

Primary DI
B377GMR1602008X0
Brand
CapSure Cloud
Company
Globalmed Holdings, LLC
Model
2.1.x
Device description
CapSure Cloud is a secure cloud-based web application for medical image archiving and management.
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K130624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130624000CONIGlobalmed2013-05-07LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B377GMR1602008X0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multidisciplinary medical image management softwareA software application intended to be used to receive, collect, store, and display a broad range of medical imaging and/or video data, and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). Also referred to as an operating room (OR) integration software, it might be designed for holographic viewing of three-dimensional (3-D) images in conjunction with an appropriate headset or for real-time communication of diagnostic/surgical images, and might also enable the control of light settings of a device (e.g., microscope) for image acquisition.

Regulatory Flags#

DUNS number
103201849
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B377GMD306100XXX0eNcounterCloud2.3.x.x2016-10-06
00085003316723ClinicalAccess® Kiosk1.01CAK0012025-06-26
00850033167221ClinicalAccess Pro Connect1.01CAP001-C01 / 1CAP001-C022025-06-26
00850033167184Smartest Persona II Multi Blood Glucose Monitoring System62762024-12-02
00850033167115eNcountereNcounter2023-12-12
00850033167108ClearStethGSW30100103GSW301001032023-12-08
00850033167122Variable Polarizing HoodGMD55100010GMD551000102023-12-08
00850033167139First Exam StationFirst Exam Station2023-12-08
00850033167146Total VitalsUSBGMR507000102023-12-08
00850033167153Total VitalsBluetoothGMR507000202023-12-08
00850033167160Total VitalsDual - BT & USBGMR507000302023-12-08
00850033167177Total ECGGMD50610001GMD506100012023-12-08
00850033167009TotalExam® 3.2 CameraGMD5504HD58GMD5504HD582023-08-04
00850033167016CAS Lite®1CSL0011CSL0012023-08-04
00850033167023TotalExam® Lite, 2.0 GMD5505HD21GMD5505HD212023-08-04
00850033167030TotalExam® Oto 2.0GMD5505HD22GMD5505HD222023-08-04
00850033167047TotalExam® Lite & Oto 2.0GMD5505HD20GMD5505HD202023-08-04
00850033167054Transportable Exam Station (TES)1TES0061TES0062023-08-04
00850033167061Clinical Access® Station (CAS)1CAS0041CAS0042023-08-04
00850033167078WallDoc®1WDC0031WDC0032023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20