Faxitron

GUDID 00857069006203

Stationary digital specimen x-ray system with 6x15 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.

FAXITRON BIOPTICS, LLC

Stationary specimen x-ray system, digital

• Primary Device ID: 00857069006203
• NIH Device Record Key: 8b8009cf-fbe6-4aef-8d7b-d2ef6e576b1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faxitron
• Version Model Number: VersaVision 6x15
• Company DUNS: 968877360
• Company Name: FAXITRON BIOPTICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857069006203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170786

FDA Product Code

• MWP: Cabinet,X-Ray System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-09

On-Brand Devices [Faxitron]

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• 00857069006203: Stationary digital specimen x-ray system with 6x15 cm imager intended for the verification of ha
• 00857069006197: Stationary digital specimen x-ray system with 12x15 cm imager intended for the verification of h
• 00857069006180: Stationary digital specimen x-ray system with 10x15 cm imager intended for the verification of h
• 00857069006050: Stationary digital specimen x-ray system with 23x29cm imager intended for the examination of Cor
• 00857069006043: Mobile digital specimen x-ray system with 12x15 cm imager for the examination of Biopsy excision
• 00857069006036: Mobile digital specimen x-ray system with 10x10 cm imager for the examination of Biopsy excision
• 00857069006029: Mobile digital specimen x-ray system with 10x12.5 cm imager for the examination of Biopsy excisi
• 00857069006012: Mobile digital specimen x-ray system with 10x15 cm imager for the examination of Biopsy excision
• 00857069006005: Stationary digital specimen x-ray system with 5x10 cm imager intended for the examination of Cor