510(k) · Cleared
ClearedQCT Pro Asynchronous Calibration Module, Cliniqct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mindways Software, Inc. · KGI Densitometer, Bone
Cleared on Aug 29, 2014 as substantially equivalent to K894854 (Image Enhancements, 1989) and 2 other predicates after a 199-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Aug 29, 2014
- Review
- 199 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K883280 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK883280 Hologic QDR-1000 X-Ray Bone Densitometer/ModifiedHologic, Inc. · 1988
- 2 generations backK002113 Ctxa Hip; Ctxa; QCT Pro Ctxa HipMindways Software, Inc. · 2001
- 1 generation backK030330 Ctxa Hip Extended Reference DataMindways Software, Inc. · 2003
- This deviceK140342 QCT Pro Asynchronous Calibration Module, CliniqctMindways Software, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883280 | Hologic QDR-1000 X-Ray Bone Densitometer/Modified | Hologic, Inc. | 1988 | — |
| −2 | K002113 | Ctxa Hip; Ctxa; QCT Pro Ctxa Hip | Mindways Software, Inc. | 2001 | — |
| −1 | K030330 | Ctxa Hip Extended Reference Data | Mindways Software, Inc. | 2003 | — |
| 0 (this device) | K140342 | QCT Pro Asynchronous Calibration Module, Cliniqct | Mindways Software, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGI device
- #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K894854 | QCT Bone Mineral Density Analysis SoftwareSummary page 4…Bone Mineral Densitometer Classification Name: Bone Densitometer, 21 CFR 892.1170, Class II Predicate Devices: K894854: Mindways QCT Pro Bone Mineral Density Analysis Software… | 1989 |
| * | K002113 | Ctxa Hip; Ctxa; QCT Pro Ctxa HipSummary page 5…Use: Estimate bone mineral density within the spine. 5-1 K002113: Mindways QCT Pro CTXA Hip Bone Mineral Densitometer Intended Use: Es… | 2001 |
| * | K030330 | Ctxa Hip Extended Reference DataSummary page 5…Estimate bone mineral density at the proximal femur, T-Score calculation, aid in determining fracture risk. K030330: QCT Pro CTXA Hip Extended Reference Data Intended Use: Reference data for Z-Score calculation betw… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K894854.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 2025
MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 5 | 173 | 6 | 2 |
| 2009 | 1 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 5 |
| 2012 | 5 | 142 | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 3 | 156 | 0 | 8 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however, provide an additional means of obtaining calibration data that does not require the…
Read the full statement (165 words)
The QCT Pro Asynchronous Calibration Module is intended to provide an alternative method for
calibrating QCT data sets that are intended for analysis with QCT Pro Spine and Hip application
modules. Installation of the QCT Pro Asynchronous Calibration Module does not alter the
clinical indications for use of the QCT Pro Spine and Hip application modules. It does, however,
provide an additional means of obtaining calibration data that does not require the simultaneous
scanning of a patient with a CT calibration standard as is required when using the QCT Pro
Spine and Hip application modules without the installation of the QCT Pro Asynchronous
Calibration Module. Thus the QCT Pro Asynchronous Calibration Module facilitates: (1)
retrospective assessment of bone density from CT scans acquired for other purposes, (2)
assessment of bone density in conjunction with another medically appropriate procedure
involving CT scans of the anatomical regions where estimating bone density is prescribed, and
(3) assessment of bone density without a phantom as an independent measurement procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140342: QCT Pro Asynchronous Calibration Module, Cliniqct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140342
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026