PROcedure Rehearsal Studio PROcedure Rehearsal Studio

GUDID 00816847021371

Image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning.

3D SYSTEMS, INC.

Radiology DICOM image processing application software

• Primary Device ID: 00816847021371
• NIH Device Record Key: 77bf4113-8648-4da3-b316-89e0f9af50f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROcedure Rehearsal Studio
• Version Model Number: 2.0.1.
• Catalog Number: PROcedure Rehearsal Studio
• Company DUNS: 085049749
• Company Name: 3D SYSTEMS, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com
• Phone: +97239114444
• Email: Simbionix@3DSystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816847021371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153705

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: 2016-09-23

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