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510(k) Data Aggregation
K Number
K082402Device Name
OSDX HIP BMD SYSTEM
Manufacturer
IMAGING THERAPEUTICS, INC.
Date Cleared
2008-10-16
(57 days)
Product Code
KGI
Regulation Number
892.1170Why did this record match?
Applicant Name (Manufacturer) :
IMAGING THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OsDx Hip BMD System stand-alone software is intended to provide an estimate of the bone mineral density (BMD) of the proximal femur using digital antero-posterior hip or pelvis radiographic images. This information may be used by the physician in the assessment of fracture risk in conjunction with the World Health Organization ("WHO") criteria and to compare the derived BMD estimate with reference populations of young (20 - 39) and age matched normals to compute T-scores and Z-scores respectively.
Device Description
The OsDx Hip BMD System is a software package that provides an estimate of BMD based on analysis of data derived from scanned hip X-rays. The program utilizes a quantitative bone structural algorithm that measures a composite of weighted cortical and trabecular parameters in proximal femur projection radiographs from which total hip bone mineral density (BMD) is mathematically derived. Image analysis can take place remotely or at the point of care.
The results, expressed as gm/cm2, can be used for comparison to a reference data base of young normals (T-score) or age-matched controls (Z-Score).
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K Number
K033242Device Name
KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
Manufacturer
IMAGING THERAPEUTICS, INC.
Date Cleared
2003-12-31
(85 days)
Product Code
HSH
Regulation Number
888.3590Why did this record match?
Applicant Name (Manufacturer) :
IMAGING THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or uni-compartmental arthroplasty procedures. The implant is indicated for the un-cemented treatment of the medial and/or lateral tibial articulating surfaces of the following:
Moderate degeneration of the medial or lateral compartment of the knee (grade II-IV chondromalacia) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral compartments.
The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is intended to be implanted in the knee as a non-fixated, intra-articular support with minimal to no movement of the device after implantation.
Device Description
Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is a minimally invasive, bone preserving, approach for the treatment of the osteoarthritic knee. Developed from patient Magnetic Resonance (MR) scans a patient specific implant is designed.
The treatment allows for the placement of an un-cemented metallic device designed from the patient's natural cartilage and meniscal geometry that is implanted into the joint space either in the medial or lateral compartment above the affected tibial plateau. The femur then articulates against the smooth implant surface. The implant is manufactured from cobalt chromium molybdenum alloy.
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