FDA.reportPublic FDA data

Ziehm Vision2 Vario 3D

Primary DI
EZIEZIEHMVISIONV3D1
Brand
Ziehm Vision2 Vario 3D
Company
Ziehm Imaging GmbH
Model
30236
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073346000ZIEHM VISION 2Ziehm Imaging, Inc.2008-03-21JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZIEZIEHMVISIONV3D1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mobile general-purpose fluoroscopic x-ray system, digitalA mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
322720541
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EZIEZIEHM80001Ziehm 800080002020-03-12
EZIEZIEHMSOLO1Ziehm SoloSolo2016-09-23
EZIEZIEHMVISIONR1Ziehm Vision RVision R2016-09-23
EZIEZIEHMVISIONFD1651Ziehm Vision FDVision FD2020-03-12
EZIEZIEHMVISIONRFD3D1Ziehm Vision RFD 3DVision RFD 3D2016-09-23
EZIEZIEHMVISIONRFD1Ziehm Vision RFDVision RFD2016-09-23
EZIEZIEHMSOLOFD1Ziehm Solo FDSolo FD2016-11-17
EZIEZIEHMVISION1Ziehm Vision2303552016-09-23
EZIEZIEHMVISIONFDV1Ziehm Vision2 FD Vario302392016-09-23
EZIEZIEHMVISIONFDV3D1Ziehm Vision2 FD Vario 3D302382016-09-23
EZIEZIEHMVISIONV1Ziehm Vision2 Vario302372016-09-23
EZIEZIEHMVISIONFD1Ziehm Vision2 FD302082016-09-23
EZIEZIEHM8000Ziehm 80003080002020-03-12
EZIEZIEHMVISIONFD165Ziehm Vision FD302891; 3029292020-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
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10884521851184superDimensionCovidien LPJAK2026-05-29
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
10810068810858MONARCH™ ControllerAuris Health, Inc.JAK2026-05-27
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12