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Mindways Software, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000012877 FEI 1000124212

Mindways Software, Inc. is a medical device manufacturer based in the United States, with 19 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class I and IIa) as of 14 Nov 2026.

Devices
19
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 13
  • EUDAMED 4
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 15
  • EU Class I 3
  • EU Class IIa 1
Top EMDN categories
Identifiers
  • EUDAMED SRN US-MF-000012877
  • FDA FEI 1000124212
  • DUNS 964202592

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What Mindways Software, Inc. makes

Mindways Software, Inc. develops software applications for analyzing bone density using CT scans, including volumetric spine and hip measurement tools. Their products also include calibration phantoms and reference data sets for densitometry testing. Examples include QCT PRO volumetric spine software, CTXA hip densitometers, and calibration phantoms like the Model 4 CT Calibration Phantom.

The company’s portfolio is regulated under FDA’s 510(k) and UDI systems in the US and listed in the EU’s eudamed registry. Devices fall into Class I, Class II, and Class IIa classifications. The manufacturer is based in the United States.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue19

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000012877
FDA FEI number
1000124212
DUNS number
964202592
EUDAMED status
Active
EUDAMED registered name
Mindways Software, Inc.
Registered address
3001, S Lamar Blvd, 78704, Austin, TX, United States
Website
www.qct.com
Phone
+1 (512) 912 0871
PRRC contact
Joren Brown(public in EUDAMED)

From the company website

Read 18 Oct 2026

Mindways produces software-based solutions to measure bone density from CT scans. Our CliniQCT and QCT Pro product families can be used for a broad range of clinical and research applications. If you have a CT scanner, we have a bone density solution.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Mindways Software, Inc. have in the registry?

The registry currently lists 19 devices for Mindways Software, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Mindways Software, Inc.'s devices?

Among its 19 most recently registered devices, Mindways Software, Inc. has devices listed in EUDAMED (4 devices), FDA 510(k) (3 devices) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Mindways Software, Inc.'s devices fall under?

Among its 19 most recently registered devices, the classes recorded for Mindways Software, Inc.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Mindways Software, Inc. in the registry?

The most recently registered devices listed for Mindways Software, Inc. include QCT PRO 3D Volumetric Spine Software K894854, CTXA Hip Bone Mineral Densitometer K002113, QCT Bone Mineral Density Analysis Software K894854 and Model 4 CT Calibration Phantom.

Generated automatically from registry data and not verified by a human reviewer.