Clarix Imaging Corps

Basic Information

• Brand Name: Clarix Imaging Corps
• Primary DI: 00860007231605
• Version / Model: VSI-1
• Company Name: Clarix Imaging Corporation
• Labeler DUNS: 080262024
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-01
• Public Version: 1
• Public Version Date: 2024-08-09
• Public Version Status: New
• Public Device Record Key: aa35d42a-6d52-491d-8d86-b3bb906ea4ca

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWP	Cabinet, x-ray system	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42280	Tissue specimen x-ray system IVD	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860007231605	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 45 Degrees Celsius