Faxitron

Basic Information

• Brand Name: Faxitron
• Primary DI: 00857069006036
• Version / Model: BioVision 10x10
• Company Name: FAXITRON BIOPTICS, LLC
• Labeler DUNS: 968877360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-17
• Public Version: 6
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 7e62f29b-a540-4e19-9ba9-12a4e1b28b51

Device Description

Mobile digital specimen x-ray system with 10x10 cm imager for the examination of Biopsy excisions.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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	00857069006036	GS1

Premarket Submissions

Submission Number	Supplement Number
K091558	000