FDA.reportPublic FDA data

Duet DRF

Primary DI
07290012104701
Brand
Duet DRF
Company
C.M.T. MEDICAL TECHNOLOGIES LTD.
Model
63111976
Catalog number
63640509
Published
2018-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103038000DUET DRFCmt Medical Technologies, Ltd.2011-03-29JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290012104701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012104701072900121047017290012104701

GMDN Terms#

Term, Definition table
TermDefinition
Stationary general-purpose fluoroscopic x-ray system, digitalA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. 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 viewed in both real-time and delayed format.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600084453
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290012104923ArtPix Fixed Lite636487962021-06-30
07290012104916ArtPix Mobile Lite636480952021-04-15
07290012104602ArtPiX Mobile EZ2GO628337652018-09-10
07290012104909ArtPIX DRF636275892020-10-18
07290012104800Presto DR 4143Optimum10041432018-09-10
07290012104817Presto DR 4343Optimum624980352018-09-10
07290012104824Presto DR 3543 EZ Optimum628213782018-09-10

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Primary DI, Brand, Company table
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00195451000560Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000577Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
00195451000584Shockwave IVL System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc.JAA2024-04-17
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