510(k) · Cleared
ClearedFractureDetect (FX)
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
Cleared on Jul 30, 2020 as substantially equivalent to DEN180005 (Imagen Technologies, Inc., 2018) after a 234-day review. Its family tree reaches back 1 generation to 2018. 8 later devices descend from it.
- Decided
- Jul 30, 2020
- Review
- 234 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180005 (2018). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- This deviceK193417 FractureDetect (FX)Imagen Technologies, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK220164 RayvolveAzmed Sas · 2022
- Descendant · cites it directly · 3 of its ownK212365 BoneViewGleamer · 2022
- Descendant · 2 generations on · 2 of its ownK240845 RayvolveAzmed Sas · 2024
- Descendant · 3 generations on · 1 of its ownK260378 RayvolveAZmed · 2026
- Descendant · 2 generations on · 1 of its ownK222176 BoneViewGleamer · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K220164RayvolveAzmed Sas · 2022 · cites it directly3descendants
- K212365BoneViewGleamer · 2022 · cites it directly3descendants
- K240845RayvolveAzmed Sas · 2024 · 2 generations on2descendants
- K260378RayvolveAZmed · 2026 · 3 generations on1descendant
- K222176BoneViewGleamer · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| 0 (this device) | K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020 | — |
| +1 | K220164 | Rayvolve | Azmed Sas | 2022 | — |
| +1 | K212365 | BoneView | Gleamer | 2022 | — |
| +2 | K240845 | Rayvolve | Azmed Sas | 2024 | — |
| +3 | K260378 | Rayvolve | AZmed | 2026 | — |
| +2 | K222176 | BoneView | Gleamer | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | DEN180005 | OsteoDetectSummary page 4…gulation: 21 CFR 892.2090 Regulatory Class: II Product Code: QBS 3. PREDICATE DEVICE Predicate Device: OsteoDetect (DEN180005) 510(k) Summary – K193417 Page 2 of 8 4.… | 2018 |
What descends from it? (8)
2 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?
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. 2020, 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?
FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only. FX is indicated for radiographs of the following industry-standard radiographic views and study types. Study Type (Anatomic+Area of Interest) | Radiographic View(s) Supported* Ankle | Frontal, Lateral, Oblique Clavicle | Frontal…
Read the full statement (147 words)
FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.
FX is indicated for radiographs of the following industry-standard radiographic views and study types.
Study Type (Anatomic+Area of Interest) | Radiographic View(s) Supported*
Ankle | Frontal, Lateral, Oblique
Clavicle | Frontal
Elbow | Frontal, Lateral
Femur | Frontal, Lateral
Forearm | Frontal, Lateral
Hip | Frontal, Frog Leg Lateral
Humerus | Frontal, Lateral
Knee | Frontal, Lateral
Pelvis | Frontal
Shoulder | Frontal, Lateral, Axillary
Tibia / Fibula | Frontal, Lateral
Wrist | Frontal, Lateral, Oblique
*For the purposes of this table, “Frontal” is considered inclusive of both posteroanterior (PA) and anteroposterior (AP) views.
+Definitions of anatomic area of interest and radiographic views are consistent with the American College of Radiology (ACR) standards and guidelines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193417: FractureDetect (FX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193417
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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