← Back to catalogue

Halifax Imaging Kit

FDA UDI

Class II (US FDA UDI)

by Halifax Biomedical Incorporated

Identity

Trade Name
Halifax Imaging Kit FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, digital FDA UDI
Device Name
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. FDA UDI
Model / Reference
1 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
P008943 FDA UDI
Primary DI / UDI-DI
00628451892021 FDA UDI
FDA Product Code
MQB FDA UDI
LLZ FDA UDI
KPR FDA UDI
GMDN Term
Stationary basic diagnostic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1680 FDA UDI
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Stationary basic diagnostic x-ray system, digital

Halifax Imaging Kit by Halifax Biomedical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary basic diagnostic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Halifax Biomedical Incorporated

Sources (1)

  • FDA UDI 848e6f3f-8bc5-481d-969b-9b9245aa0840 35 fields · synced May 31, 2026