FDA.reportPublic FDA data

GIOTTO IMAGE

Primary DI
08056977360076
Brand
GIOTTO IMAGE
Company
IMS GIOTTO SPA
Model
GIOTTO IMAGE 3DL/3MP
Catalog number
6909
Published
2021-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MUEFull Field Digital, System, X-Ray, Mammographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUEFull Field Digital, System, X-Ray, MammographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111434000GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-LGiotto USA, LLC2011-10-27MUE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056977360073PackageGS11In Commercial Distribution
28056977360070PackageGS11In Commercial Distribution
38056977360077PackageGS11In Commercial Distribution
08056977360076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805697736007318056977360073
2805697736007028056977360070
3805697736007738056977360077
08056977360076080569773600768056977360076

GMDN Terms#

Term, Definition table
TermDefinition
Stationary mammographic x-ray system, digitalA stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).

Regulatory Flags#

DUNS number
437701793
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056977360113SMART FINDER 28000-022023-06-25
08056977360007GIOTTO CLASSGIOTTO CLASS 3D30000-yy2021-03-23
08056977360014GIOTTO CLASS GIOTTO CLASS 3D READY30010-yy2021-03-23
08056977360038GIOTTO CLASS GIOTTO CLASS S 3D 40000-yy2021-03-23
08056977360045GIOTTO CLASS GIOTTO CLASS S READY40010-yy2021-03-23
08056977360052GIOTTO CLASS GIOTTO CLASS S 2D40004-yy2021-03-23
08056977360069GIOTTO IMAGE GIOTTO IMAGE 3DL69072021-03-23
08056977360083GIOTTO IMAGE GIOTTO IMAGE M6501M12021-03-23
08056977360106MAMMOBEDMAMMOBED6100-06M12021-03-23
18056977360004GIOTTO CLASSGIOTTO CLASS 3D30000-yy2021-03-23
18056977360011GIOTTO CLASS GIOTTO CLASS 3D READY30010-yy2021-03-23
08056977360021GIOTTO CLASS GIOTTO CLASS 2D30001-yy2021-03-23
18056977360035GIOTTO CLASS GIOTTO CLASS S 3D 40000-yy2021-03-23
18056977360042GIOTTO CLASS GIOTTO CLASS S READY40010-yy2021-03-23
18056977360059GIOTTO CLASS GIOTTO CLASS S 2D40004-yy2021-03-23
18056977360066GIOTTO IMAGE GIOTTO IMAGE 3DL69072021-03-23
18056977360073GIOTTO IMAGEGIOTTO IMAGE 3DL/3MP69092021-03-23
18056977360080GIOTTO IMAGE GIOTTO IMAGE M6501M12021-03-23
08056977360090BIOPSY DIGIT BIOPSY DIGIT SL9201-01M12021-03-23
18056977360103MAMMOBEDMAMMOBED6100-06M12021-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052405210203SERENYS DRMETALTRONICA SPAMUE2026-05-25
08052405210050HELIANTHUSMETALTRONICA SPAMUE2026-03-24
00198953109281Senographe PristinaGE MEDICAL SYSTEMSMUE2025-12-01
10198953054311not applicableGE MEDICAL SYSTEMSMUE2025-11-28
08809244065088GenorayGENORAY CO., LTD.MUE2025-07-24
15420045517851Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517882Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517899Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517905Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517912Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517929Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517936Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517943Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517950Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517967Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517974Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517981Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517998Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
08809394330357VIVIX-M 1824SVIEWORKS CO., LTD.MUE2025-07-15
08809394330364VIVIX-M 2430SVIEWORKS CO., LTD.MUE2025-07-15
088000186022562430TCARayence Co., Ltd.MUE2025-04-08
00195278914026Senographe PristinaGE MEDICAL SYSTEMSMUE2025-01-09
10195278901764Not ApplicableGE MEDICAL SYSTEMSMUE2025-01-09
00195278866899not applicableGE MEDICAL SYSTEMSMUE2024-06-07
04056869987187MAMMOMAT B.brilliantSiemens Healthcare GmbHMUE2024-04-20
00195278719812not applicableGE MEDICAL SYSTEMSMUE2024-04-11
00195278795724not applicableGE MEDICAL SYSTEMSMUE2024-01-22
00195278711229not applicableGE MEDICAL SYSTEMSMUE2023-09-14
00195278655141not applicableGE MEDICAL SYSTEMSMUE2023-07-28
00195278661999Senographe PristinaGE MEDICAL SYSTEMSMUE2023-07-28