Halifax Imaging Kit - The Halifax Imaging Kit is part of the SR Suite - Halifax Biomedical Incorporated

Duns Number:241237150

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

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More Product Details

Catalog Number

P008943

Brand Name

Halifax Imaging Kit

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KPR

Product Code Name

System, X-Ray, Stationary

Device Record Status

Public Device Record Key

848e6f3f-8bc5-481d-969b-9b9245aa0840

Public Version Date

April 16, 2018

Public Version Number

1

DI Record Publish Date

March 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HALIFAX BIOMEDICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2