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510(k) Data Aggregation
K Number
K111443Device Name
X12 STERILE REFLECTIVE MARKER SPHERE
Manufacturer
PINSCO INC. DBA B & L ENGINEERING
Date Cleared
2011-09-29
(128 days)
Product Code
OLO, HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
**PINSCO INC. DBA B **& L ENGINEERING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.
Device Description
X12's Sterile Reflective Marker Spheres consist of two hemispheres, coated with a retroreflective foil, bonded together on a central pin to form a sphere. The central pin can be threaded with an M3 female thread or have a snap hole to mate with a mounting pin. The retro-reflective foil is applied in such a way as to provide reflectivity from all angles that is equivalent to the predicate devices. The spheres are individually packaged in a special sterile package and are gamma sterilized.
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K Number
K982425Device Name
CODA MPX30 MOTION ANALYSIS SYSTEM
Manufacturer
PINSCO INC. DBA B & L ENGINEERING
Date Cleared
1998-10-07
(86 days)
Product Code
LXJ
Regulation Number
890.5360Why did this record match?
Applicant Name (Manufacturer) :
**PINSCO INC. DBA B **& L ENGINEERING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coda mpx30 system has general application to measurement and recording of 3D position and movement, including human movement. It is appropriate for use in assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions of either a neurological or orthopaedic cause.
Device Description
CODA mpx30 is an optical/electronic system which measures and analyses the 3D position and movement of markers placed on the limbs of patients whose movement function is to be assessed.
Dimensions: 30mm wide x 114mm high x 250mm deep Weight : 11 kg
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