De Novo · Granted
GrantedOsteoDetect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imagen Technologies, Inc. · QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Granted on May 24, 2018 as a new device type through De Novo after a 108-day review. 50 later devices descend from it.
- Decided
- May 24, 2018
- Review
- 108 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
50 later devices descend from it, 4 citing it directly.
- This deviceDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- Descendant · cites it directly · 32 of its ownK181704 TransparaScreenpoint Medical B.V. · 2018
- Descendant · 2 generations on · 9 of its ownK193229 TransparaScreenpoint Medical B.V. · 2020
- Descendant · cites it directly · 8 of its ownK193417 FractureDetect (FX)Imagen Technologies, Inc. · 2020
- Descendant · cites it directly · 7 of its ownK182373 PowerLook Tomo Detection V2 SoftwareIcad, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK192287 TransparaScreenpoint Medical B.V. · 2019
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K181704TransparaScreenpoint Medical B.V. · 2018 · cites it directly32descendants
- K193229TransparaScreenpoint Medical B.V. · 2020 · 2 generations on9descendants
- K193417FractureDetect (FX)Imagen Technologies, Inc. · 2020 · cites it directly8descendants
- K182373PowerLook Tomo Detection V2 SoftwareIcad, Inc. · 2018 · cites it directly7descendants
- K192287TransparaScreenpoint Medical B.V. · 2019 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| +1 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| +2 | K193229 | Transpara | Screenpoint Medical B.V. | 2020 | — |
| +1 | K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020 | — |
| +1 | K182373 | PowerLook Tomo Detection V2 Software | Icad, Inc. | 2018 | — |
| +2 | K192287 | Transpara | Screenpoint Medical B.V. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 9 | 0 |
| 2025 | 6 | 0 |
| 2026 | 12 | 0 |
Sources: FDA De Novo 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 QBS? 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 QBS device
- #1 K260378 Rayvolvescore 15.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (50)
See all 504 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K181704 (Screenpoint Medical B.V., 2018) has gone furthest, with 32 descendants of its own.
How does its category compare?
All QBS devicesQBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QBS
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QBS
123in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QBS
No recall names QBS since 2007.
Adverse event reports per year · QBS
No MAUDE report names QBS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 123 | 0 | — |
What is it indicated for?
OsteoDetect analyzes wrist radiographs using machine learning techniques to identify and highlight distal radius fractures during the review of posterior-anterior (PA) and lateral (LAT) radiographs of adult wrists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180005 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180005: OsteoDetect.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180005
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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