Presto DR 4343Optimum

GUDID 07290012104817

C.M.T. MEDICAL TECHNOLOGIES LTD.

Stationary basic diagnostic x-ray system, digital
Primary Device ID07290012104817
NIH Device Record Keyd53fa52e-39b0-4cbf-87c9-3968157dfee9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePresto DR 4343Optimum
Version Model Number62498035
Company DUNS600084453
Company NameC.M.T. MEDICAL TECHNOLOGIES LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290012104817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-11
Device Publish Date2018-09-10

Devices Manufactured by C.M.T. MEDICAL TECHNOLOGIES LTD.

07290012104923 - ArtPix Fixed Lite2021-07-08
07290012104916 - ArtPix Mobile Lite2021-04-23
07290012104909 - ArtPIX DRF2020-10-26
07290012104602 - ArtPiX Mobile EZ2GO2018-10-11
07290012104701 - Duet DRF2018-10-11
07290012104800 - Presto DR 4143Optimum2018-10-11
07290012104817 - Presto DR 4343Optimum2018-10-11
07290012104817 - Presto DR 4343Optimum2018-10-11
07290012104824 - Presto DR 3543 EZ Optimum2018-10-11

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