Halifax Imaging Kit P008943

GUDID 00628451892021

The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path to creating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing DR system are synchronized by replacing the trigger switches of the two systems with the Halifax Synchronization Switch. The Halifax Synchronization Switch ensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray images from two different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR). RSA is a stereo x-ray technique that enables measurements more accurate and precise than single plane radiography based on phantom studies. The increased level of precision enables measurement of implant stability.

Halifax Biomedical Incorporated

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00628451892021
• NIH Device Record Key: 848e6f3f-8bc5-481d-969b-9b9245aa0840
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halifax Imaging Kit
• Version Model Number: 1
• Catalog Number: P008943
• Company DUNS: 241237150
• Company Name: Halifax Biomedical Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 9029452771
• Email: info@halifaxbiomedical.com
• Phone: 9029452771
• Email: info@halifaxbiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628451892021 [Primary]

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-04-16
• Device Publish Date: 2018-03-14

Devices Manufactured by Halifax Biomedical Incorporated

• 00628451892021 - Halifax Imaging Kit: 2018-04-16The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path to creating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing DR system are synchronized by replacing the trigger switches of the two systems with the Halifax Synchronization Switch. The Halifax Synchronization Switch ensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray images from two different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR). RSA is a stereo x-ray technique that enables measurements more accurate and precise than single plane radiography based on phantom studies. The increased level of precision enables measurement of implant stability.
• 00628451892021 - Halifax Imaging Kit: 2018-04-16 The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path to creating an SR Suite. The Halifax
• 00628451892014 - Tantalum Bead Set: 2018-03-29 Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue