FDA.reportPublic FDA data

Ziehm 8000

Primary DI
EZIEZIEHM8000
Brand
Ziehm 8000
Company
Ziehm Imaging GmbH
Model
308000
Published
2020-03-12
Public version status
New
Distribution status
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
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190497000Ziehm 8000Ziehm Imaging GmbH2019-11-20OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZIEZIEHM8000PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
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
EZIEZIEHMVISIONV3D1Ziehm Vision2 Vario 3D302362016-09-23
EZIEZIEHMVISIONV1Ziehm Vision2 Vario302372016-09-23
EZIEZIEHMVISIONFD1Ziehm Vision2 FD302082016-09-23
EZIEZIEHMVISIONFD165Ziehm Vision FD302891; 3029292020-03-12

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