FDA.reportPublic FDA data

BIOPSY DIGIT

Primary DI
08033837190219
Brand
BIOPSY DIGIT
Company
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
Model
BIOPSY DIGIT AM
Catalog number
9100-01
Device description
Biopsy Digit device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. It is intended to mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
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
K990192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990192000BIOPSY-DIGITSitco, Inc.1999-03-12IZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033837190216PackageGS11In Commercial Distribution
08033837190219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803383719021618033837190216
08033837190219080338371902198033837190219

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth303Millimeter
Height347Millimeter
Width350Millimeter

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
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
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