CAAS Qardia

GUDID 08056304454928

Pie Medical Imaging B.V.

Radiology DICOM image processing application software

• Primary Device ID: 08056304454928
• NIH Device Record Key: b91962e6-c5d7-4963-aa8d-cedfdab1ae26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAAS Qardia
• Version Model Number: 2.0
• Company DUNS: 413761941
• Company Name: Pie Medical Imaging 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: false
• 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

Customer Support Contacts

• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl
• Phone: +31308500202
• Email: support@pie.nl

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056304454928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212376

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-04
• Device Publish Date: 2023-01-13

On-Brand Devices [CAAS Qardia]

• 08056304454928: 2.0
• 08056304454768: 1.1
• 08056304455369: 2.1