Simpleware Medical

GUDID 00860011545705

Simpleware Medical image processing. Applicable software versions (UDI-PI) 00860011545705(8012)V-2024.06

SYNOPSYS, INC.

Radiological PACS software

• Primary Device ID: 00860011545705
• NIH Device Record Key: c66c8473-59a2-48f8-9d92-88ef0aed4267
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpleware Medical
• Version Model Number: V-2024.06 -
• 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: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com
• Phone: +4401392642635
• Email: simpleware-qms@synopsys.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011545705 [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: 2024-06-18
• Device Publish Date: 2024-06-10

Devices Manufactured by SYNOPSYS, INC.

• 00860011545705 - Simpleware Medical: 2024-06-18Simpleware Medical image processing. Applicable software versions (UDI-PI) 00860011545705(8012)V-2024.06
• 00860011545705 - Simpleware Medical: 2024-06-18 Simpleware Medical image processing. Applicable software versions (UDI-PI) 00860011545705(8012)V-2024.06
• 00863520000352 - Synopsys Simpleware ScanIP: 2023-10-18
• 00863520000369 - Synopsys Simpleware ScanIP: 2023-10-18
• 00863520000390 - Simpleware ScanIP Medical: 2021-06-15 Current software release: S-2021.06 Simpleware ScanIP Medical is intended for use as a software interface and image segmentation
• 00863520000383 - Simpleware ScanIP Medical: 2021-03-17
• 00863520000376 - Simpleware ScanIP Medical: 2020-09-16
• 00863520000307 - Simpleware ScanIP: 2019-10-07
• 00863520000314 - Simpleware ScanIP: 2019-10-07