FDA.reportPublic FDA data

GIOTTO IMAGE 3DL

Primary DI
08033837190042
Brand
GIOTTO IMAGE 3DL
Company
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
Model
GIOTTO IMAGE_20'' 2Mpixel
Catalog number
6907
Device description
GIOTTO IMAGE is a mammography unit with motorized tube rotation ± 240 for stereotactic biopsy.
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
08033837190042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033837190042080338371900428033837190042

GMDN Terms#

Term, Definition table
TermDefinition
Mammographic x-ray system stereotactic unitA device that can only fulfil its purpose when used together with and enhance the function of a diagnostic mammographic x-ray system. It is used to take two pictures of a breast from two different angles. On the basis of this stereoscopic picture set, it is possible to determine the exact position of a lesion in the breast and a cytological sample of this will be taken. This device or technique may be built-in to some diagnostic x-ray systems for mammography.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth1140Millimeter
Height2240Millimeter
Width1150Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius70 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
08033837190028GIOTTO IMAGE 3DLAmorphous Selenium detector D752016-09-22
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