FDA.reportPublic FDA data

Faxitron

Primary DI
00857069006012
Brand
Faxitron
Company
FAXITRON BIOPTICS, LLC
Model
BioVision 10x15
Device description
Mobile digital specimen x-ray system with 10x15 cm imager for the examination of Biopsy excisions.
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
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
K091558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091558000BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEMBioptics, Inc.2009-07-17MWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857069006012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857069006012008570690060128570690060120857069006012

GMDN Terms#

Term, Definition table
TermDefinition
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.

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
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
00857069006197FaxitronVersaVision 12x152017-08-04
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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