Presto DR 4143Optimum

GUDID 07290012104800

C.M.T. MEDICAL TECHNOLOGIES LTD.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 07290012104800
• NIH Device Record Key: 1237e720-998d-42c2-b9f0-a4c9b1be35f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Presto DR 4143Optimum
• Version Model Number: 1004143
• Company DUNS: 600084453
• Company Name: C.M.T. MEDICAL TECHNOLOGIES LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290012104800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110849

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-11
• Device Publish Date: 2018-09-10

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

• 07290012104923 - ArtPix Fixed Lite: 2021-07-08
• 07290012104916 - ArtPix Mobile Lite: 2021-04-23
• 07290012104909 - ArtPIX DRF: 2020-10-26
• 07290012104602 - ArtPiX Mobile EZ2GO: 2018-10-11
• 07290012104701 - Duet DRF: 2018-10-11
• 07290012104800 - Presto DR 4143Optimum: 2018-10-11
• 07290012104800 - Presto DR 4143Optimum: 2018-10-11
• 07290012104817 - Presto DR 4343Optimum: 2018-10-11
• 07290012104824 - Presto DR 3543 EZ Optimum: 2018-10-11