Halifax Biomedical Incorporated

Address:10984 Highway 19,Mabou Nova Scotia,CA

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Premarket Exempt
Clear
- Catalog Number : P005603

Device Description : Tantalum bead implants are used as radio-opaque markers and may be implanted int Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue

Device Class : 2

Duns Number: 241237150

Premarket Exempt : Yes

Product Code : NEU

Prescription Use : Yes

Device Count : 1

- Catalog Number : P008943

Device Description : The Halifax Imaging Kit is part of the SR Suite product line, provides an altern 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.

Device Class : 2

Duns Number: 241237150

Premarket Exempt : Yes

Product Code : MQB, LLZ, KPR

Prescription Use : Yes

Device Count : 1