FDA.reportPublic FDA data

Clarix Imaging Corps

Primary DI
00860007231605
Brand
Clarix Imaging Corps
Company
Clarix Imaging Corporation
Model
VSI-1
Device description
The Clarix Imaging Volumetric Specimen Imager (VSI) is a portable, fully shielded cabinet X-ray system that provides high resolution 2D and 3D radiographic images of surgically excised specimens.
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MWPCabinet, x-ray system

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007231605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007231605008600072316058600072316050860007231605

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080262024
Device count
1
Lot or batch
true
Serial number
true

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
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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