510(k) · Cleared
ClearedBoneView
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gleamer · QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Cleared on Mar 2, 2023 as substantially equivalent to K212365 (Gleamer, 2022) after a 223-day review. Its family tree reaches back 3 generations to 2018. 1 later device descends from it.
- Decided
- Mar 2, 2023
- Review
- 223 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180005 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 2 generations backK193417 FractureDetect (FX)Imagen Technologies, Inc. · 2020
- 1 generation backK212365 BoneViewGleamer · 2022
- This deviceK222176 BoneViewGleamer · 2023
- Descendant · cites it directly · 0 of its ownK242171 TechCare TraumaMilvue · 2025
Most influential descendants
Showing 1 of 1 · See all- K242171TechCare TraumaMilvue · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −2 | K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020 | — |
| −1 | K212365 | BoneView | Gleamer | 2022 | — |
| 0 (this device) | K222176 | BoneView | Gleamer | 2023 | — |
| +1 | K242171 | TechCare Trauma | Milvue | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K212365 | BoneViewSummary page 4…CFR 892.2090 Product Code QBS Classification Class II 3. Predicate Device Predicate Device Gleamer BoneView 510(k) reference K212365 GLEAMER 5 avenue du Général de Gaulle, 94160 Sa… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242171 | TechCare Trauma | 2025 | 0 |
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. 2023, 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?
BoneView 1.1-US is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs of:
Ankle, foot, knee, tibia/fibula, wrist, hand, elbow, forearm, humerus, shoulder, and clavicle in adults and children/adolescents; and pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine in adults only. Compatible radiographic views are frontal, lateral, and/or oblique views as applicable to the study type.
BoneView 1.1-US is intended for use as a concurrent reading aid during the interpretation of radiographs.
BoneView 1.1-US is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222176: BoneView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222176
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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