Simpleware ScanIP Medical

GUDID 00863520000390

Current software release: S-2021.06 Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning. For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.

SYNOPSYS, INC.

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• Primary Device ID: 00863520000390
• NIH Device Record Key: 24b62db0-aee3-4b32-b3cf-b347e360b29f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpleware ScanIP Medical
• Version Model Number: S-2021.06 onwards
• Company DUNS: 161499579
• Company Name: SYNOPSYS, 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: false
• 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: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com
• Phone: +4401392428750
• Email: simpleware@synopsys.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863520000390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203195

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: 2021-06-15
• Device Publish Date: 2021-06-07

On-Brand Devices [Simpleware ScanIP Medical]

• 00863520000376: R-2020.09
• 00863520000383: R-2021.03
• 00863520000390: Current software release: S-2021.06 Simpleware ScanIP Medical is intended for use as a software