FDA.reportPublic FDA data

Faxitron

Primary DI
00857069006197
Brand
Faxitron
Company
FAXITRON BIOPTICS, LLC
Model
VersaVision 12x15
Device description
Stationary digital specimen x-ray system with 12x15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but can also be used with film.
Published
2017-08-04
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
MWPCabinet,X-Ray System

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170786000Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC2017-07-18MWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857069006197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857069006197008570690061978570690061970857069006197

GMDN Terms#

Term, Definition table
TermDefinition
Stationary specimen x-ray system, digitalA stationary specimen x-ray system designed for permanent fixture in one location to generate and control x-ray beams and to record the absorption patterns of x-rays passing through tissue samples (e.g., stereotactic biopsy cores taken during mammographic procedures) or amputated body parts. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968877360
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857069006265Faxitron ORBioVision 10x152019-07-02
00857069006012FaxitronBioVision 10x152016-08-17
00857069006029FaxitronBioVision 10x12.52016-08-17
00857069006036FaxitronBioVision 10x102016-08-17
00857069006043FaxitronBioVision Plus 12x152016-08-17
00857069006210FaxitronBioVision +2018-06-05
00857069006272Faxitron CoreCoreVision 5x102019-07-02
00857069006289Faxitron PathPathVision 23x292019-07-02
00857069006227FaxitronVisionCT 15x152018-08-04
00857069006005FaxitronCoreVision 5x102016-08-17
00857069006050FaxitronPathVision 23x29 cm2016-08-17
00857069006180FaxitronVersaVision 10x152017-08-04
00857069006203FaxitronVersaVision 6x152017-08-09

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
25420045516646FAXITRON MAMMOTOMEHologic, 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
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