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CTXA Hip Extended Reference Data

FDA UDI

Class II (US FDA UDI)

by Mindways Software, Inc.

Identity

Trade Name
CTXA Hip Extended Reference Data FDA UDI
Generic Name
CT system application software FDA UDI
Device Name
The CTXA Hip Extended Reference Data is an accessory to the CTXA Hip Bone Mineral Densitometer. The CTXA Hip Extended Reference Data is used within the CTXA Hip module to calculate T-scores and percent young normal for any patient, and Z-scores for patients age 20-80 for BMD estimates made using the CTXCA Hip module. TThe intended use of the CTXA Hip Extended Reference Data accessory for the CTXA Hip Bone Mineral Densitometry module is to provide a context for the clinical interpretation of a patient's proximal femur BMD estimates. The use of a reference data set and the interpretation of parameters derived by the CTXA Hip module when comparing patient-specific BMD estimates to the installed and selected reference data set is at the discretion of the physician. The predicate K002113 CTXA Hip Bone Mineral Densitometer Module (CTXA Hip) provides estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from DXA devices. These BMD estimates from the predicate device are compared to a reference database of age 20-39 US Caucasian females to calculate T-scores and percent young normal for patient BMD estimates and Z-scores for patient BMD estimates for ages 20-39. The current CTXA Hip Extended Reference Data is an accessory to CTXA Hip that also is used to calculate T-scores and percent young normal, and also is used to calculate Z-scores for ages 20-80. The CTXA Hip BMD estimates referenced to the CTXA Hip Extended Reference Data reference population are used as an aid to the physician in identifying patients with low bone mineral density and as an aid in determining a patient's fracture risk. BMD estimates obtained with CTXA Hip with Extended Reference Data accessory are identical to BMD estimates obtained with the predicate CTXA Hip. T-scores calculated with CTXA Hip with Extended Refecrence Data accessory are slightly less negative or less positive than those calculated with CTXA Hip,approximately 0.1-0.2 T-score units. FDA UDI
Model / Reference
K030330 FDA UDI
Description
The CTXA Hip Extended Reference Data is an accessory to the CTXA Hip Bone Mineral Densitometer. The CTXA Hip Extended Reference Data is used within the CTXA Hip module to calculate T-scores and percent young normal for any patient, and Z-scores for patients age 20-80 for BMD estimates made using the CTXCA Hip module. TThe intended use of the CTXA Hip Extended Reference Data accessory for the CTXA Hip Bone Mineral Densitometry module is to provide a context for the clinical interpretation of a patient's proximal femur BMD estimates. The use of a reference data set and the interpretation of parameters derived by the CTXA Hip module when comparing patient-specific BMD estimates to the installed and selected reference data set is at the discretion of the physician. The predicate K002113 CTXA Hip Bone Mineral Densitometer Module (CTXA Hip) provides estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from DXA devices. These BMD estimates from the predicate device are compared to a reference database of age 20-39 US Caucasian females to calculate T-scores and percent young normal for patient BMD estimates and Z-scores for patient BMD estimates for ages 20-39. The current CTXA Hip Extended Reference Data is an accessory to CTXA Hip that also is used to calculate T-scores and percent young normal, and also is used to calculate Z-scores for ages 20-80. The CTXA Hip BMD estimates referenced to the CTXA Hip Extended Reference Data reference population are used as an aid to the physician in identifying patients with low bone mineral density and as an aid in determining a patient's fracture risk. BMD estimates obtained with CTXA Hip with Extended Reference Data accessory are identical to BMD estimates obtained with the predicate CTXA Hip. T-scores calculated with CTXA Hip with Extended Refecrence Data accessory are slightly less negative or less positive than those calculated with CTXA Hip,approximately 0.1-0.2 T-score units. FDA UDI

Identifiers

Catalog Number
DI_CTXAHIPEXTDB FDA UDI
Primary DI / UDI-DI
B052DICTXAHIPEXTDB0 FDA UDI
510(k) Number
K030330 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 Extended Reference Data by Mindways Software, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CT system application software.

Cleared under the same submission

K030330 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mindways Software, Inc.

Sources (1)

  • FDA UDI d9efaa5b-399f-49b5-bcdb-22a78fe98aaf 36 fields · synced Jun 9, 2026