Simpleware ScanIP Medical

Primary DI
00863520000390
Brand
Simpleware ScanIP Medical
Company
SYNOPSYS, INC.
Model
S-2021.06 onwards
Device description
Final software release for UDI-DI: T-2022.03. 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.
Published
2021-06-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203195000Simpleware ScanIP MedicalSynopsys (Northern Europe) , Ltd.2021-04-01LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863520000390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863520000390008635200003908635200003900863520000390

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
+4401392428750simpleware@synopsys.com

Regulatory Flags#

DUNS number
161499579
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011545705Simpleware MedicalV-2024.06 -2024-06-10
00863520000352Synopsys Simpleware ScanIPQ-2020.062020-06-08
00863520000369Synopsys Simpleware ScanIPQ-2020.032020-05-27
00863520000383Simpleware ScanIP MedicalR-2021.032021-03-09
00863520000376Simpleware ScanIP MedicalR-2020.092020-09-08
00863520000345Synopsys Simpleware ScanIPP-2019.092019-09-09
00863520000321Simpleware ScanIPN-2018.032018-03-12
00863520000338Synopsys Simpleware ScanIPO-2018.122018-12-10
00863520000307Simpleware ScanIP2016.092016-10-03
00863520000314Simpleware ScanIPM-2017.062017-06-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
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00754016387111ANDIImeka Solutions IncLLZ2023-09-01
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00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
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00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01