FDA.reportPublic FDA data

CuattroDR

Primary DI
B269SWR00069MD0
Brand
CuattroDR
Company
Cuattro Medical
Model
SWR-00069-MD
Device description
CuattroDR System Software
Published
2017-05-26
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
KPRSystem, X-Ray, Stationary
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161937000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161937000CuattroDRCuattro, LLC2016-10-06KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B269SWR00069MD0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-709-4514medsupport@cuattro.com

Regulatory Flags#

DUNS number
014513888
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B269SWR00021MD0CloudDR™SWR-00021-MD2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08437021468175QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2025-07-04
088000186022562430TCARayence Co., Ltd.LLZ2025-04-08
07630542730153MyShoulder PlannerMedacta International SALLZ2025-02-06
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
08056304455727G-scan OpenESAOTE SPALLZ2024-07-02
08056600520044Nical Flat PanelNICAL SPALLZ2023-10-09
G221200CA3080iQ ViewFirst Source, Inc.LLZ2023-06-13
07630542715679Advanced MyHip PlannerMedacta International SALLZ2023-01-26
07630030855818MyHip bone modelMedacta International SALLZ2023-01-23
07630030855825MyHip bone modelMedacta International SALLZ2023-01-23
07630030855832MyHip bone modelMedacta International SALLZ2023-01-23
07630030855849MyHip bone modelMedacta International SALLZ2023-01-23
07630345729286Advanced MyHip PlannerMedacta International SALLZ2023-01-23
088000186007262430MCARayence Co., Ltd.LLZ2021-06-28
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
07630971257603MyHip PlannerMedacta International SALLZ2020-11-06