DEVICE: Halifax Imaging Kit (00628451892021)
Device Identifier (DI) Information
Halifax Imaging Kit
1
In Commercial Distribution
P008943
Halifax Biomedical Incorporated
1
In Commercial Distribution
P008943
Halifax Biomedical Incorporated
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37645 | Stationary basic diagnostic x-ray system, digital |
An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
LLZ | System, Image Processing, Radiological |
KPR | System, X-Ray, Stationary |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
848e6f3f-8bc5-481d-969b-9b9245aa0840
April 16, 2018
1
March 14, 2018
April 16, 2018
1
March 14, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
9029452771
info@halifaxbiomedical.com
info@halifaxbiomedical.com