FDA.reportPublic FDA data

Affirm Breast Biopsy Guidance System

Primary DI
15420045507197
Brand
Affirm Breast Biopsy Guidance System
Company
Hologic, Inc.
Model
ASY-03669
Catalog number
ASY-03669
Published
2017-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZHSystem, x-ray, mammographic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25420045507194PackageGS11In Commercial Distribution
15420045507197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2542004550719425420045507194
1542004550719715420045507197

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
139534114
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15420045518131Selenia® Dimensions®ASY-10775-2DASY-10775-2D2026-03-12
15420045518148Selenia® Dimensions®ASY-10775-3DASY-10775-3D2026-03-12
15420045518155Selenia® Dimensions®ASY-10775-2D-UPSASY-10775-2D-UPS2026-03-12
15420045518162Selenia® Dimensions®ASY-10775-3D-UPSASY-10775-3D-UPS2026-03-12
15420045518179Selenia® Dimensions®ASY-10775-2D-CNASY-10775-2D-CN2026-03-12
15420045518186Selenia® Dimensions®ASY-08483-2DASY-08483-2D2026-03-12
15420045518193Selenia® Dimensions®ASY-10775-3D-CNASY-10775-3D-CN2026-03-12
15420045518216Selenia® Dimensions®ASY-08483-3DASY-08483-3D2026-03-12
15420045518223Selenia® Dimensions®ASY-08483-3D-CNASY-08483-3D-CN2026-03-12
15420045518230Selenia® Dimensions®ASY-08483-2D-CNASY-08483-2D-CN2026-03-12
15420045518247Affirm Prone Biopsy SystemPBX-SYS-AFFIRM-3D-CNPBX-SYS-AFFIRM-3D-CN2026-03-12
15420045518261Affirm Prone Biopsy SystemPBX-SYS-AFFIRM-2D-CNPBX-SYS-AFFIRM-2D-CN2026-03-12
15420045518278Affirm Prone Biopsy SystemASY-06886-CNASY-06886-CN2026-03-12
15420045518285Affirm Prone Biopsy SystemASY-09175-CNASY-09175-CN2026-03-12
15420045518292Affirm Prone Biopsy SystemASY-08832-CNASY-08832-CN2026-03-12
15420045516236EnvisionASY-14621ASY-146212025-11-13
15420045516243EnvisionASY-14622ASY-146222025-11-13
15420045516250EnvisionASY-14623ASY-146232025-11-13
15420045516267EnvisionASY-14624ASY-146242025-11-13
15420045516274EnvisionASY-14625ASY-146252025-11-13

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
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
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
15420045506541Affirm Prone Biopsy SystemHologic, Inc.IZH2017-02-06
00840682123297Senographe Essential StereotaxyGE MEDICAL SYSTEMSIZH2016-12-29
04547410327342FDR-2000BPYFUJIFILM CORPORATIONIZH2016-12-14