FDA.reportPublic FDA data

GIOTTO IMAGE 3DL

Primary DI
08033837190028
Brand
GIOTTO IMAGE 3DL
Company
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
Model
Amorphous Selenium detector
Catalog number
D75
Device description
It's an amorphous selenium detector 24 x 30 cm that directly captures x-rays and converts the them into electronic signal from which the images are constructed.
Published
2016-09-22
Public version status
Update
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
18033837190025PackageGS11In Commercial Distribution
08033837190028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803383719002518033837190025
08033837190028080338371900288033837190028

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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth348Millimeter
Height35Millimeter
Width347Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Regulatory Flags#

DUNS number
429113525
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033837190035GIOTTO IMAGE 3DLMAW6006-15GM32016-09-22
08033837190011GIOTTO IMAGE 3DLGIOTTO IMAGE_20'' 3Mpixel69092016-09-22
08033837190042GIOTTO IMAGE 3DLGIOTTO IMAGE_20'' 2Mpixel69072016-09-22
08033837190059GIOTTO IMAGE 3DLGIOTTO IMAGE_21'' 2Mpixel69022016-09-22
08033837190103GIOTTO IMAGEGIOTTO IMAGE M65012016-09-22
08033837190110GIOTTO IMAGEGIOTTO IMAGE SRA67022016-09-22
08033837190202BIOPSY DIGITBIOPSY DIGIT SL9201-012016-09-22
08033837190219BIOPSY DIGITBIOPSY DIGIT AM9100-012016-09-22
08033837190301MAMMOBEDMAMMOBED6100-06M12016-09-22

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