FDA.reportPublic FDA data

Simpleware ScanIP

Primary DI
00863520000307
Brand
Simpleware ScanIP
Company
SYNOPSYS, INC.
Model
2016.09
Published
2016-10-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K142779000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142779000SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MEDSimpleware , Ltd.2015-04-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863520000307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863520000307008635200003078635200003070863520000307

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
161499579
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011545705Simpleware MedicalV-2024.06 - 2024-06-10
00863520000390Simpleware ScanIP MedicalS-2021.06 onwards2021-06-07
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
00863520000314Simpleware ScanIPM-2017.062017-06-05
00863520000321Simpleware ScanIPN-2018.032018-03-12
00863520000338Synopsys Simpleware ScanIPO-2018.122018-12-10

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