Data / Medical devices / United States / Mindways Software, Inc.
Mindways Software, Inc.: FDA-registered device maker in Austin, TX, United States, 4 510(k) clearances
Mindways Software, Inc. is registered with the FDA (registration 2939827) in Austin, TX, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated August 29, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2939827
- FEI number
- 1000124212
- Address
- 3001 S Lamar Blvd Ste 302, Austin, TX, United States, 78704
- Owner or operator
- MINDWAYS SOFTWARE, INC. (9000592)
- Roles
- Manufacturer
- First device listed
- January 3, 2008
- Registered through
- 2027
- Brand names listed
- CTXA, CTXA HIP, HIP QCT PRO BMD, QCT BMD, QCT PRO, QCT PRO Asynchronous Calibration Module (CLINIQCT)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Densitometer, Bone | KGI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 29, 2014 | K140342 | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT | KGI | Substantially Equivalent | Mindways Software, Inc. | accessdata.fda.gov |
| June 20, 2003 | K030330 | CTXA HIP EXTENDED REFERENCE DATA | KGI | Substantially Equivalent | Mindways Software, Inc. | accessdata.fda.gov |
| December 4, 2001 | K002113 | CTXA HIP; CTXA; QCT PRO CTXA HIP | KGI | Substantially Equivalent | Mindways Software, Inc. | accessdata.fda.gov |
| October 19, 1989 | K894854 | QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE | KGI | Substantially Equivalent | Image Enhancements | accessdata.fda.gov |
Compare with other makers
Updated August 29, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.