FDA.reportPublic FDA data

Mammographic stereotactic biopsy system

Definition
An 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.
GUDID devices
184
Last updated
2026-10-04 01:44:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841911103776Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.MRPROBE082026-06-09
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.BXS1002026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.Bexcore System-BXS1002026-06-01
00801741079535VACORA®Bard Peripheral Vascular, Inc.VBD10102016-09-20
00801741079542VACORA®Bard Peripheral Vascular, Inc.VBD14102016-09-20
00801741086717ENCOR®SENORX, INC.SCTUB30002016-09-20
00801741086724ENCOR ULTRA®SENORX, INC.SCTUB40002016-09-20
00801741182365EleVation™Bard Peripheral Vascular, Inc.EVDRIVER2020-06-18
00801741182464EleVation™Bard Peripheral Vascular, Inc.EVREFURB2020-06-18
00801741182471EleVation™Bard Peripheral Vascular, Inc.EVLOANER2020-06-18
00811870030710CUSTOM HEALTHCARE SYSTEMS INCManus Medical, LLCB9-18339B2018-10-02
00811870031137Custom Healthcare Systems Inc.Manus Medical, LLCB446MM-B2018-07-29
00811870033254Custom Healthcare Systems Inc.Manus Medical, LLCB9-179722018-07-31
00811870033360Custom Healthcare Systems Inc.Manus Medical, LLCB9-17972A2018-07-26
00811870035227Custom Healthcare Systems Inc.Manus Medical, LLCB9-183392018-07-27
00859013006017MPM Medical Supply (Private Label)MANAN MEDICAL PRODUCTS, INC.KOP20032017-01-05
00859013006024MPM Medical Supply (Private Label)MANAN MEDICAL PRODUCTS, INC.KOP20052017-01-12
00859013006055MPM Medical Supply (Private Label)MANAN MEDICAL PRODUCTS, INC.KOP20072017-01-05
00859013006062MPM Medical Supply (Private Label)MANAN MEDICAL PRODUCTS, INC.KOP20102017-01-05
08033837190202BIOPSY DIGITI.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRLBIOPSY DIGIT SL2016-09-22
08033837190219BIOPSY DIGITI.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRLBIOPSY DIGIT AM2016-09-22
10801741086691ENCOR®SENORX, INC.SCCAN012016-09-22
10801741086707ENCOR ULTRA®SENORX, INC.SCCAN022016-09-22
17350081940048NeoNavia Biopsy SystemNeoDynamics AB (publ)11032023-03-20
17350081940086NeoNavia Biopsy SystemNeoDynamics AB (publ)11022023-03-20
00841911100508Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.MRTARGET082026-03-13
00841911102281Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.MRCM12026-03-13
00841911102496Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.MRBC12026-03-13
00841911102632Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.MRB12026-03-13
15420045518247Affirm Prone Biopsy SystemHologic, Inc.PBX-SYS-AFFIRM-3D-CN2026-03-12
15420045518261Affirm Prone Biopsy SystemHologic, Inc.PBX-SYS-AFFIRM-2D-CN2026-03-12
15420045518278Affirm Prone Biopsy SystemHologic, Inc.ASY-06886-CN2026-03-12
15420045518285Affirm Prone Biopsy SystemHologic, Inc.ASY-09175-CN2026-03-12
15420045518292Affirm Prone Biopsy SystemHologic, Inc.ASY-08832-CN2026-03-12
00801741234194EnCor EnCompass™Bard Peripheral Vascular, Inc.ENCPST2026-02-03
00801741234248EnCor EnCompass™Bard Peripheral Vascular, Inc.ENCPDriver2026-02-03
00801741234262EnCor EnCompass™Bard Peripheral Vascular, Inc.ENCPFS2026-02-03
00801741235221EnCor EnCompass™Bard Peripheral Vascular, Inc.ENCPConsole2026-02-03
00841911102861Mammotome Revolve EX HolsterDEVICOR MEDICAL PRODUCTS, INC.MHEXH12025-09-18
00841911102335Mammotome Revolve EXDEVICOR MEDICAL PRODUCTS, INC.MHEXH12025-08-28
00841911102366Mammotome Revolve EXDEVICOR MEDICAL PRODUCTS, INC.MHEXHOLD12025-08-28
15420045518087Affirm®Hologic, Inc.STLC-00004-CN2025-07-17
00841911102830Control Module- Revolve EXDEVICOR MEDICAL PRODUCTS, INC.MSCM12025-05-08
00841911103165Mammotome RevolveDEVICOR MEDICAL PRODUCTS, INC.MSCM12024-11-20
00841911102328Mammotome RevolveDEVICOR MEDICAL PRODUCTS, INC.MSCM12024-07-18
00801741086496EnCorSENORX, INC.ENCFNGUIDE012024-04-15
15420045512948AFFIRM™ CONTRAST BIOPSYHologic, Inc.AFFIRM™ CONTRAST BIOPSY SOFTWARE2020-11-18
15420045515161Brevera Breast Biopsy SystemHologic, Inc.BREVDRV-022024-02-15
08056977360113SMART FINDER IMS GIOTTO SPA28000-022023-06-25
00841911102823Mammotome eliteDEVICOR MEDICAL PRODUCTS, INC.MEH12023-06-01
27350081940045NeoNavia Biopsy SystemNeoDynamics AB (publ)11032023-03-20
27350081940083NeoNavia Biopsy SystemNeoDynamics AB (publ)11022023-03-20
00841911101796MammotomeDEVICOR MEDICAL PRODUCTS, INC.SCM122022-02-09
00841911101802MammotomeDEVICOR MEDICAL PRODUCTS, INC.SCM232022-02-09
00841911101833MammotomeDEVICOR MEDICAL PRODUCTS, INC.SCMSW62022-02-09
00841911101840MammotomeDEVICOR MEDICAL PRODUCTS, INC.STCH12022-02-09
00841911101895Mammotome revolveDEVICOR MEDICAL PRODUCTS, INC.MSTH12022-02-08
00841911102045Mammotome revolveDEVICOR MEDICAL PRODUCTS, INC.MHUSH12022-02-08
00841911102267Mammotome revolveDEVICOR MEDICAL PRODUCTS, INC.MSCM12022-02-08
00841911101703Mammotome eliteDEVICOR MEDICAL PRODUCTS, INC.MEH12022-02-07
10841911101236MammotomeDEVICOR MEDICAL PRODUCTS, INC.VAS082022-02-04
10841911101243MammotomeDEVICOR MEDICAL PRODUCTS, INC.VAS112022-02-04
15420045512931AFFIRM™ SPECIMEN IMAGINGHologic, Inc.AFFIRM™ SPECIMEN IMAGING2021-07-10
15420045512863Brevera Breast Biopsy SystemHologic, Inc.BREVDISP092020-08-20
15420045510845Affirm Prone Biopsy SystemHologic, Inc.PBX-SYS-AFFIRM-2D2019-09-19
15420045510852Affirm Prone Biopsy SystemHologic, Inc.PBX-SYS-AFFIRM-2D2019-09-19
15420045510869Affirm Prone Biopsy SystemHologic, Inc.PBX-SYS-AFFIRM-2D2019-09-19
15420045507821Brevera Breast Biopsy SystemHologic, Inc.BREVSTYLBRKT2019-04-02
15420045509726EvivaHologic, Inc.EVIVA_ADAPTER2019-04-02
15420045509733EvivaHologic, Inc.Eviva_STX_KIT_13cm2019-04-02
15420045509740EvivaHologic, Inc.EVIVA_ADAPTER_MTEST2019-04-02
15420045509757EvivaHologic, Inc.EVIVA_STYLET_BRACKET2019-04-02
15420045509764EvivaHologic, Inc.EVIVA_NG_HOLDER2019-04-02
15420045509771EvivaHologic, Inc.FAB-063372019-04-02
15420045509788ATECHologic, Inc.SR3060-012019-04-02
15420045509795ATECHologic, Inc.SR3090-012019-04-02
15420045509801ATECHologic, Inc.SR3000-012019-04-02
15420045509818ATECHologic, Inc.SR3000-042019-04-02
15420045509825ATECHologic, Inc.ATEC STX-12019-04-02
15420045509832ATECHologic, Inc.ATEC STX-22019-04-02