Identity
- Trade Name
- CTXA Hip Bone Mineral Densitometer FDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- The CTXA Hip Bone Mineral Densitometer (CTXA Hip) is a software package intended for estimation of bone mineral content (BMC), in grams, and bone mineral density (BMD), in g/cm2, of the proximal femur. The CTXA Hip uses quantitative computed tomography (QCT) methods to derive bone mass and bone density estimates from 3D CT image data sets obtained from compatible, whole-body CT scanners and with compatible CT calibration phantoms. BMD estimates are derived in units of g/cm2 equivalent K2HPO4 density. The BMD estimates can be compared with CTCA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores ca be used by the physician an an aid in determining fracture risk. CTXA Hip uses the same technical procedures to acquire and calibrate CT image data as are used for the predicate device K894854: QCT Bone Mineral Density Analysis Software. CTXA Hip reference data for young normal US Caucasian females were acquired in a clinical study, so that patient results obtained using CTXA Hip can be compared to this normal reference population. The CTXA Hip BMD estimates compared to the CTXA Hip reference population are sued as an aid to the physician in identifying patients with low bone mineral density. Additionally, normal data comparisons provide a basis for estimating fracture risk. BMC and BMD estimates are returned by the CTXA Hip for the following proximal femur regions of interest (ROIs): (1) femoral neck, (2) trochanter, (3) intertrochanter, (4) Ward’s triangle, and (5) total hip (i.e., superposition of ROIs 1-3). FDA UDI
- Model / Reference
- K002113 FDA UDI
- Description
- The CTXA Hip Bone Mineral Densitometer (CTXA Hip) is a software package intended for estimation of bone mineral content (BMC), in grams, and bone mineral density (BMD), in g/cm2, of the proximal femur. The CTXA Hip uses quantitative computed tomography (QCT) methods to derive bone mass and bone density estimates from 3D CT image data sets obtained from compatible, whole-body CT scanners and with compatible CT calibration phantoms. BMD estimates are derived in units of g/cm2 equivalent K2HPO4 density. The BMD estimates can be compared with CTCA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores ca be used by the physician an an aid in determining fracture risk. CTXA Hip uses the same technical procedures to acquire and calibrate CT image data as are used for the predicate device K894854: QCT Bone Mineral Density Analysis Software. CTXA Hip reference data for young normal US Caucasian females were acquired in a clinical study, so that patient results obtained using CTXA Hip can be compared to this normal reference population. The CTXA Hip BMD estimates compared to the CTXA Hip reference population are sued as an aid to the physician in identifying patients with low bone mineral density. Additionally, normal data comparisons provide a basis for estimating fracture risk. BMC and BMD estimates are returned by the CTXA Hip for the following proximal femur regions of interest (ROIs): (1) femoral neck, (2) trochanter, (3) intertrochanter, (4) Ward’s triangle, and (5) total hip (i.e., superposition of ROIs 1-3). FDA UDI
Identifiers
- Catalog Number
- DI_CTXAHIP FDA UDI
- Primary DI / UDI-DI
- B052DICTXAHIP0 FDA UDI
- 510(k) Number
- K002113 FDA UDI
- FDA Product Code
- KGI FDA UDI
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1170 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CT system application software
CTXA Hip Bone Mineral Densitometer by Mindways Software, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002113 also covers:
- Model 4 CT Calibration Phantom — Mindways Software, Inc.
- QCT PRO 3D Volumetric Spine Software — Mindways Software, Inc.
- QCT PRO 3D Volumetric Spine and CTXA Hip Software — Mindways Software, Inc.
- QCT PRO 3D Volumetric Spine and CTXA Hip System — Mindways Software, Inc.
- QCT PRO Asynchronous 3D Spine Software — Mindways Software, Inc.
- QCT PRO Asynchronous 3D Spine and CTXA-Hip System — Mindways Software, Inc.
- QCT PRO Asynchronous 3D Spine and CTXA-Hip System — Mindways Software, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mindways Software, Inc.
Sources (1)
- FDA UDI 78731cf4-5bc1-4d3c-b2fe-d0e8dd5e0674 36 fields · synced Jun 9, 2026