FDA.reportPublic FDA data

CubeVue

Primary DI
00863152000379
Brand
CubeVue
Company
CURVEBEAM, LLC
Model
3.7.0
Device description
3D visualization software
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K181962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181962000CubeVueCurvebeam, LLC2018-08-07LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863152000379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863152000379008631520003798631520003790863152000379

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068780729
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863152000362CubeVue 3.6.02018-09-10
00860004550020HiRise1040-1152021-01-20
00860004550037HiRise1040-2302021-01-20
00863152000348LineUP1030-1152018-09-10
00863152000355LineUP1030-2302018-09-10
00863152000300PedCAT1000-1152017-08-01
00863152000317PedCAT1000-2302017-08-01
00863152000324In Reach1020-1152017-08-01
00863152000331In Reach1020-2302017-08-01

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Primary DI, Brand, Company table
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00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
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00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
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00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05