Simpleware ScanIP

GUDID 00863520000307

SYNOPSYS, INC.

Radiology DICOM image processing application software

• Primary Device ID: 00863520000307
• NIH Device Record Key: fc67cff7-057e-4768-8fc4-4a5214f0b2be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpleware ScanIP
• Version Model Number: 2016.09
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863520000307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142779

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: 2016-10-03

On-Brand Devices [Simpleware ScanIP]

• 00863520000321: N-2018.03
• 00863520000314: M-2017.06
• 00863520000307: 2016.09