Selenia Dimensions C-View Software

Primary DI
15420045500020
Brand
Selenia Dimensions C-View Software
Company
Hologic, Inc.
Model
C-View
Catalog number
SW-03052
Device description
Selenia® Dimensions® C-View Software is a software feature where a standard digital mammography image is generated from data acquired during a standard resolution breast tomosynthesis scan.
Published
2014-09-05
Public version status
Update
Distribution status
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
OTEDigital breast tomosynthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTEDigital Breast TomosynthesisUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080003001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080003001SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMHologic, Inc.2011-02-11OTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045500020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550002015420045500020

GMDN Terms#

Term, Definition table
TermDefinition
Basic x-ray clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
139534114
Device count
1
DM exempt
true
Premarket exempt
false
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

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15420045513983BioZorbF0202F02022021-04-21
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15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11
15420045504585ATEC IntroducerAI120920AI1209202016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045518131Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518148Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518155Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518162Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518179Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518186Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518193Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518216Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518223Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518230Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
00198953109281Senographe PristinaGE MEDICAL SYSTEMSOTE2025-12-01
10198953054311not applicableGE MEDICAL SYSTEMSOTE2025-11-28
15420045516236EnvisionHologic, Inc.OTE2025-11-13
15420045516243EnvisionHologic, Inc.OTE2025-11-13
15420045516250EnvisionHologic, Inc.OTE2025-11-13
15420045516267EnvisionHologic, Inc.OTE2025-11-13
15420045516274EnvisionHologic, Inc.OTE2025-11-13
15420045516281EnvisionHologic, Inc.OTE2025-11-13
15420045516304EnvisionHologic, Inc.OTE2025-11-13
15420045516311EnvisionHologic, Inc.OTE2025-11-13
15420045516328EnvisionHologic, Inc.OTE2025-11-13
15420045516335EnvisionHologic, Inc.OTE2025-11-13
15420045516342EnvisionHologic, Inc.OTE2025-11-13
15420045516359EnvisionHologic, Inc.OTE2025-11-13
15420045516366EnvisionHologic, Inc.OTE2025-11-13
15420045516373EnvisionHologic, Inc.OTE2025-11-13
15420045516380EnvisionHologic, Inc.OTE2025-11-13
15420045516397EnvisionHologic, Inc.OTE2025-11-13
15420045516403EnvisionHologic, Inc.OTE2025-11-13
15420045516410EnvisionHologic, Inc.OTE2025-11-13