CAAS Workstation

GUDID 08056304454461

Pie Medical Imaging B.V.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: 08056304454461
• NIH Device Record Key: 7bdfc6e4-37d7-4898-8545-5eef2af131f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAAS Workstation
• Version Model Number: 8.5
• 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
• 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
• Phone: +31308500202
• Email: support@pie.nl

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056304454461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180019

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: 2021-05-31
• Device Publish Date: 2021-05-21

On-Brand Devices [CAAS Workstation]

• 08056304454058: Development ongoing
• 08056304451200: 7.2
• 08056304451194: 7.1
• 08056304454003: 8.1
• 08056304453761: 8.0
• 08056304453440: 7.5
• 08056304453099: 7.4
• 08056304454331: 8.4
• 08056304454461: 8.5
• 08056304455314: 8.5.3