FDA.reportPublic FDA data

FAXITRON MAMMOTOME

Primary DI
25420045516646
Brand
FAXITRON MAMMOTOME
Company
Hologic, Inc.
Model
120-807604
Device description
Container with a base and a lid to hold surgical specimen sample for the purpose of x-ray imaging that sample
Published
2023-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWPCabinet, x-ray system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWPCabinet, X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082432000CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEMBioptics, Inc.2008-11-21MWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25420045516646PrimaryGS10
15420045516649Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2542004551664625420045516646
1542004551664915420045516649

GMDN Terms#

Term, Definition table
TermDefinition
Tissue specimen x-ray system IVDAn assembly of devices designed to produce an x-ray image of a tissue sample (e.g., stereotactic biopsy cores taken during mammographic procedures) and/or an amputated body part, by generating and controlling x-ray beams and recording the absorption patterns of the x-rays. The system typically includes a cabinet where the specimen is placed and a screen; the image is generated via digital imaging methods.

Contacts#

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

Regulatory Flags#

DUNS number
139534114
Device count
25
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06
15420045500518ProcleixUltrio Plus Negative Calibrators3032602014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060508820062Solas ORCIRDAN IMAGING LIMITEDMWP2026-05-05
B619X40QF0XPERT40KubtecMWP2025-03-26
B619X42QK0XPERT42KubtecMWP2025-03-26
B619X80LAR0XPERT80LKubtecMWP2025-03-26
B619X80QT0XPERT80KubtecMWP2025-03-26
B619X84R3XPERT84KubtecMWP2025-03-26
00860007231605Clarix Imaging CorpsClarix Imaging CorporationMWP2024-08-01
15420045516656FAXITRON WEDGEHologic, Inc.MWP2023-05-25
06974970580074TrueViewCompAI Healthcare (Suzhou) Co.,ltdMWP2023-05-17
06974970580081TrueViewCompAI Healthcare (Suzhou) Co.,ltdMWP2023-05-17
25420045516622FAXITRON COREHologic, Inc.MWP2023-04-11
15420045516625FAXITRON COREHologic, Inc.MWP2023-04-11
15420045516649FAXITRON MAMMOTOMEHologic, Inc.MWP2023-04-11
15420045514898FAXITRON ULTRAFOCUSHologic, Inc.MWP2022-07-12
15420045514911Faxitron CTHologic, Inc.MWP2021-10-07
15420045514836FAXITRON PATHHologic, Inc.MWP2021-08-17
15420045514928Faxitron Path+Hologic, Inc.MWP2021-08-17
15420045515031FAXITRON PATHHologic, Inc.MWP2021-07-30
15420045514218FAXITRON COREHologic, Inc.MWP2021-07-15
06973166110026TrueViewCompAI Healthcare (Shenzhen) Co.,ltdMWP2021-01-22
00887868199097Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199103Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199110Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199127Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199134Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199141Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199158Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199165Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199172Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13
00887868199189Timberline® MPF Lateral Interbody Modular Plate Fixation SystemBIOMET SPINE LLCMWP2020-07-13