FDA.report

SecurViewRT Mammorgraphy Workstation

Primary DI
15420045507364
Brand
SecurViewRT Mammorgraphy Workstation
Company
Hologic, Inc.
Model
SVRT
Published
2018-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LMDSystem, digital image communications, radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15420045507364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1542004550736415420045507364

GMDN Terms

TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags

DUNS number
139534114
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DIBrandModelCatalogPublished
15420045518131Selenia® Dimensions®ASY-10775-2DASY-10775-2D2026-03-12
15420045518148Selenia® Dimensions®ASY-10775-3DASY-10775-3D2026-03-12
15420045518155Selenia® Dimensions®ASY-10775-2D-UPSASY-10775-2D-UPS2026-03-12
15420045518162Selenia® Dimensions®ASY-10775-3D-UPSASY-10775-3D-UPS2026-03-12
15420045518179Selenia® Dimensions®ASY-10775-2D-CNASY-10775-2D-CN2026-03-12
15420045518186Selenia® Dimensions®ASY-08483-2DASY-08483-2D2026-03-12
15420045518193Selenia® Dimensions®ASY-10775-3D-CNASY-10775-3D-CN2026-03-12
15420045518216Selenia® Dimensions®ASY-08483-3DASY-08483-3D2026-03-12
15420045518223Selenia® Dimensions®ASY-08483-3D-CNASY-08483-3D-CN2026-03-12
15420045518230Selenia® Dimensions®ASY-08483-2D-CNASY-08483-2D-CN2026-03-12
15420045518247Affirm Prone Biopsy SystemPBX-SYS-AFFIRM-3D-CNPBX-SYS-AFFIRM-3D-CN2026-03-12
15420045518261Affirm Prone Biopsy SystemPBX-SYS-AFFIRM-2D-CNPBX-SYS-AFFIRM-2D-CN2026-03-12
15420045518278Affirm Prone Biopsy SystemASY-06886-CNASY-06886-CN2026-03-12
15420045518285Affirm Prone Biopsy SystemASY-09175-CNASY-09175-CN2026-03-12
15420045518292Affirm Prone Biopsy SystemASY-08832-CNASY-08832-CN2026-03-12
15420045516236EnvisionASY-14621ASY-146212025-11-13
15420045516243EnvisionASY-14622ASY-146222025-11-13
15420045516250EnvisionASY-14623ASY-146232025-11-13
15420045516267EnvisionASY-14624ASY-146242025-11-13
15420045516274EnvisionASY-14625ASY-146252025-11-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00850054590145interWORKSAvreo IncLMD2025-11-14
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
03770024341072Sonio Pro v3SONIOLMD2025-08-28
00850054590138interWORKSAvreo IncLMD2025-08-26
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12
08800184000009I-Rapha ViewIRM IncLMD2025-08-01
00612479273597McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479277359McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00612479277366McKessonMCKESSON MEDICAL-SURGICAL INC.LMD2025-07-15
00850061871268IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850061871275IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850061871282IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.LMD2025-07-14
00850025268332Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-05-16
07649988969867OptiVu StreamerINCREMED AGLMD2025-04-24
00850054590121interWORKSAvreo IncLMD2025-04-22
00300021451554Lilly TogetherELI LILLY AND COMPANYLMD2025-04-17
00300021458553Lilly TogetherELI LILLY AND COMPANYLMD2025-04-17
05415334053717BarcoBarco NVLMD2025-04-14
05415334053724BarcoBarco NVLMD2025-04-14
05415334053731BarcoBarco NVLMD2025-04-14
05415334054059BarcoBarco NVLMD2025-04-14