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QCT Pro Bone Mineral Densitometry Software, Version 6.1

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref QCTPROM0ASHModel 6.1

by Mindways Software, Inc.

Identity

Trade Name
QCT Pro Bone Mineral Densitometry Software, Version 6.1 EUDAMED
QCT PRO Asynchronous 3D Spine and CTXA-Hip Software FDA UDI
Generic Name
CT system application software FDA UDI
Device Name
QCT Pro Bone Mineral Densitometry Software EUDAMED
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 FDA UDI
Model / Reference
6.1 EUDAMED
QCTPROM0ASH EUDAMED
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 FDA UDI

Identifiers

Catalog Number
QCTPROM0ASH FDA UDI
Primary DI / UDI-DI
++B052QCTPROM0ASHF9 EUDAMED
B052QCTPROM0ASH0 FDA UDI
Basic UDI-DI
B-++B052QCTPROM0ASHF9 EUDAMED
510(k) Number
K002113 FDA UDI
K030330 FDA UDI
K140342 FDA UDI
K894854 FDA UDI
FDA Product Code
KGI FDA UDI
EMDN Code
Z11900192 BONE DENSITOMETRY SYSTEMS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
CT system application software FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1170 FDA UDI
Special Device Type
-1192 EUDAMED
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

QCT Pro Bone Mineral Densitometry Software, Version 6.1 by Mindways Software, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mindways Software, Inc.
EUDAMED SRN
US-MF-000012877
Authorised Representative
Johner Medical GmbH DE-AR-000011832

Sources (2)

  • EUDAMED ec08eb4b-e7c0-44ac-b4e5-0a11a5e410d5 61 fields · synced Jul 12, 2026
  • FDA UDI f8539c9b-769a-47d1-a2f8-0f991a657102 36 fields · synced May 30, 2026