FDA.reportPublic FDA data

GIOTTO IMAGE

Primary DI
08033837190103
Brand
GIOTTO IMAGE
Company
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
Model
GIOTTO IMAGE M
Catalog number
6501
Device description
Giotto Image is a conventional film-screen x-ray mammographic device.
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
IZHSystem, X-Ray, Mammographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZHSystem, X-Ray, MammographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012953000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012953000GIOTTO IMAGEMedx, Inc.2001-11-30IZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033837190100PackageGS11In Commercial Distribution
08033837190103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803383719010018033837190100
08033837190103080338371901038033837190103

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
Depth1140Millimeter
Height2240Millimeter
Width1150Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
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
08033837190042GIOTTO IMAGE 3DLGIOTTO IMAGE_20'' 2Mpixel69072016-09-22
08033837190059GIOTTO IMAGE 3DLGIOTTO IMAGE_21'' 2Mpixel69022016-09-22
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
15420045518247Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518261Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518278Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518285Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518292Affirm Prone Biopsy SystemHologic, Inc.IZH2026-03-12
15420045518087Affirm®Hologic, Inc.IZH2025-07-17
08056977360113SMART FINDER IMS GIOTTO SPAIZH2023-06-25
15420045512931AFFIRM™ SPECIMEN IMAGINGHologic, Inc.IZH2021-07-10
15420045512948AFFIRM™ CONTRAST BIOPSYHologic, Inc.IZH2020-11-18
00813079020400Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
00813079020417Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
00813079020424Open Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
10813079020407Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
20813079020411Closed Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
10813079020421Open Needle GuideREMINGTON MEDICAL, INC.IZH2020-09-24
B852SPECBOARD2220SPECBOARD JRMACBRUD CORPORATIONIZH2020-03-18
B852SPECBOARD4440SpecboardMACBRUD CORPORATIONIZH2020-03-18
15420045510845Affirm Prone Biopsy SystemHologic, Inc.IZH2019-09-19
15420045510852Affirm Prone Biopsy SystemHologic, Inc.IZH2019-09-19
15420045510869Affirm Prone Biopsy SystemHologic, Inc.IZH2019-09-19
25420045507347MammoPad Radiolucent CushionHologic, Inc.IZH2018-02-14
15420045507173Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-12-01
15420045507180Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-11-21
15420045507197Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-11-21
25420045507330MammoPad Radiolucent CushionHologic, Inc.IZH2017-07-26
15420045506503Affirm Prone Biopsy SystemHologic, Inc.IZH2017-04-26
15420045506510Affirm Prone Biopsy SystemHologic, Inc.IZH2017-04-26
15420045506534Affirm Prone Biopsy SystemHologic, Inc.IZH2017-04-26
15420045505926Multicare PlatinumHologic, Inc.IZH2017-03-30
15420045506077Digital Spot Mammography System, DSMHologic, Inc.IZH2017-03-30