3mensio Workstation

GUDID 08056304453488

Pie Medical Imaging B.V.

Radiology DICOM image processing application software

• Primary Device ID: 08056304453488
• NIH Device Record Key: aa9b365d-2e6b-4b3a-9a1b-0b5c4a39622f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3mensio Workstation
• Version Model Number: 8.1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056304453488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153736

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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-11-25

On-Brand Devices [3mensio Workstation]

• 08056304454225: 9.2
• 08056304454072: Development ongoing
• 08056304451224: 5.0
• 08056304451217: 8.0
• 08056304453839: 9.1
• 08056304453778: 9.0
• 08056304453495: 6.1
• 08056304453488: 8.1
• 08056304454249: 10.1
• 08056304454669: 10.3
• 08056304454942: 10.4
• 08056304454348: 10.2
• 08056304455505: 10.6