Medis Suite XA 2D

GUDID B141MEDISSUITEXA2D20180

Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vess

Medis Medical Imaging Systems B.V.

Laboratory instrument/analyser application software IVD

• Primary Device ID: B141MEDISSUITEXA2D20180
• NIH Device Record Key: faa7a1b2-ce25-4713-b227-e0e947dad345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medis Suite XA 2D
• Version Model Number: 2018
• Company DUNS: 549961191
• Company Name: Medis Medical Imaging Systems B.V.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B141MEDISSUITEXA2D20180 [Primary]
HIBCC	B141QANGIOXA730 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112807

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2018-09-07
• Device Publish Date: 2018-08-07

On-Brand Devices [Medis Suite XA 2D]

• B141MEDISSUITEXA2D20180: Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic
• B141MEDISSUITEXA2D20190: Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic