FDA.reportPublic FDA data

SMART FINDER

Primary DI
08056977360113
Brand
SMART FINDER
Company
IMS GIOTTO SPA
Model
28000-02
Device description
The SMART FINDER is intended to be used for mammographic procedures requiring stereotactic guidance,such as fine needle aspiration, needle biopsy and guide wire placement.
Published
2023-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K203509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203509000SMART FINDERIms Giotto S.P.A.2021-07-14IZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056977360113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056977360113080569773601138056977360113

GMDN Terms#

Term, Definition table
TermDefinition
Mammographic stereotactic biopsy systemAn assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.

Sterilization Methods#

Method table
Method

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
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
08056977360076GIOTTO IMAGEGIOTTO IMAGE 3DL/3MP69092021-03-23
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
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
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
15420045505858Affirm Breast Biopsy Guidance SystemHologic, Inc.IZH2017-03-18