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 ID00860011545705
NIH Device Record Keyc66c8473-59a2-48f8-9d92-88ef0aed4267
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimpleware Medical
Version Model NumberV-2024.06 -
Company DUNS161499579
Company NameSYNOPSYS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com
Phone+4401392642635
Emailsimpleware-qms@synopsys.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860011545705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-18
Device Publish Date2024-06-10

Devices Manufactured by SYNOPSYS, INC.

00860011545705 - Simpleware Medical2024-06-18Simpleware Medical image processing. Applicable software versions (UDI-PI) 00860011545705(8012)V-2024.06
00860011545705 - Simpleware Medical2024-06-18 Simpleware Medical image processing. Applicable software versions (UDI-PI) 00860011545705(8012)V-2024.06
00863520000352 - Synopsys Simpleware ScanIP2023-10-18
00863520000369 - Synopsys Simpleware ScanIP2023-10-18
00863520000390 - Simpleware ScanIP Medical2021-06-15 Current software release: S-2021.06 Simpleware ScanIP Medical is intended for use as a software interface and image segmentation
00863520000383 - Simpleware ScanIP Medical2021-03-17
00863520000376 - Simpleware ScanIP Medical2020-09-16
00863520000307 - Simpleware ScanIP2019-10-07
00863520000314 - Simpleware ScanIP2019-10-07

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