FDA.reportPublic FDA data

QAngio XA 3D

Primary DI
B141MEDISSUITEXA20190
Brand
QAngio XA 3D
Company
Medis Medical Imaging Systems B.V.
Model
2.0
Device description
QANGIO XA 3D is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QANGIO XA 3D enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, QANGIO XA 3D provides:• Quantitative results of coronary vessel segments based on a 3D reconstructed model;• Dimensions of the cardiovascular vessels and lesions;• Quantification of the pressure drop in coronary vessels.
Published
2020-01-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B141MEDISSUITEXA20190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
549961191
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B141MEDISSUITEMRCT20260Medis Suite MRCT20262026-09-25
B141QIVUS300QIvus3.02026-04-21
B141MEDISSUITEMRCT20250Medis Suite MRCT20252025-05-14
B141MEDISSUITEMRCT20230Medis Suite MRCT20232023-06-05
B141MEDISSUITEXA20230Medis Suite XA20232023-06-05
B141MEDISSUITEMRCT20220Medis Suite MRCT20222022-05-16
B141MEDISSUITEXA20220Medis Suite XA20222022-05-16
B141MEDISSUITEMRCT20190Medis Suite MRCT20192020-01-28
B141MEDISSUITEMRCT300Medis Suite MRCT3.02017-08-07
B141MEDISSUITEMRCT20210Medis Suite MRCT20212021-10-11
B141MEDISSUITEXA20210Medis Suite XA20212021-10-11
B141MEDISSUITEMRCT20200Medis Suite MRCT20202020-09-11
B141MEDISSUITEXA20200Medis Suite XA20202020-09-11
B141MEDISSUITEXA2D20190Medis Suite XA 2D20192020-02-20
B141MEDISSUITEMRCT20180Medis Suite MRCT20182018-08-07
B141MEDISSUITEMRCT210Medis Suite MRCT2.12017-03-06
B141MEDISSUITEXA2D20180Medis Suite XA 2D20182018-08-07
B141QANGIOXA730QAngio XA7.32016-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03