QCT PRO Asynchronous 3D Spine and CTXA-Hip System

FDA UDI

Class II (US FDA UDI)

by Mindways Software, Inc.

Identity

Trade Name: QCT PRO Asynchronous 3D Spine and CTXA-Hip System FDA UDI
Generic Name: CT system application software FDA UDI
Device Name: Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set FDA UDI
Model / Reference: K894854K002113K030330K140342 FDA UDI
Description: Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set FDA UDI

Identifiers

Catalog Number: QCTPROM3ASH FDA UDI
Primary DI / UDI-DI: B052QCTPROM3ASH0 FDA UDI
510(k) Number: K002113 FDA UDI
K030330 FDA UDI
K140342 FDA UDI
K894854 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: CT system application software

QCT PRO Asynchronous 3D Spine and CTXA-Hip System 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:

K030330 also covers:

K140342 also covers:

K894854 also covers:

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 9405314a-63bc-4a8d-a4b3-6b013aeeca52 37 fields · synced Jun 9, 2026