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 1, 2022 as substantially equivalent to K193417 (Imagen Technologies, Inc., 2020) after a 214-day review. Its family tree reaches back 2 generations to 2018. 3 later devices descend from it.
- Decided
- Mar 1, 2022
- Review
- 214 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180005 (2018). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 1 generation backK193417 FractureDetect (FX)Imagen Technologies, Inc. · 2020
- This deviceK212365 BoneViewGleamer · 2022
- Descendant · cites it directly · 1 of its ownK222176 BoneViewGleamer · 2023
- Descendant · 2 generations on · 0 of its ownK242171 TechCare TraumaMilvue · 2025
- Descendant · cites it directly · 0 of its ownK223491 Critical Care Suite with Pneumothorax Detection AI Algorithm…Ge Medical Systems, LLC · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −1 | K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020 | — |
| 0 (this device) | K212365 | BoneView | Gleamer | 2022 | — |
| +1 | K222176 | BoneView | Gleamer | 2023 | — |
| +2 | K242171 | TechCare Trauma | Milvue | 2025 | — |
| +1 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care… | Ge Medical Systems, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K193417 | FractureDetect (FX)Summary page 4…Product Code QBS Classification Class II 3. Predicate Device Predicate Device Imagen Technologies, Inc - FractureDetect 510(k) reference K193417 GLEAMER 5 avenue du Général de Gaulle, 94160 Saint-Ma… | 2020 |
What descends from it? (3)
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. 2022, 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 is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs of: Study Type (Anatomical Area of Interest) Compatible Radiographic View(s) Ankle Frontal, Lateral, Oblique Foot Frontal, Lateral, Oblique Knee Frontal, Lateral Tibia/Fibula Frontal, Lateral Femur Frontal, Lateral Wrist Frontal, Lateral, Oblique Hand Frontal, Oblique Elbow Frontal, Lateral Forearm Frontal…
Read the full statement (116 words)
BoneView is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs of:
Study Type (Anatomical Area of Interest) Compatible Radiographic View(s)
Ankle Frontal, Lateral, Oblique
Foot Frontal, Lateral, Oblique
Knee Frontal, Lateral
Tibia/Fibula Frontal, Lateral
Femur Frontal, Lateral
Wrist Frontal, Lateral, Oblique
Hand Frontal, Oblique
Elbow Frontal, Lateral
Forearm Frontal, Lateral
Humerus Frontal, Lateral
Shoulder Frontal, Lateral, Axillary
Clavicle Frontal
Pelvis Frontal
Hip Frontal, Frog Leg Lateral
Ribs Frontal Chest, Rib series
Thoracic Spine Frontal, Lateral
Lumbosacral Spine Frontal, Lateral
BoneView is intended for use as a concurrent reading aid during the interpretations of radiographs. BoneView is for prescription use only and is indicated for adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212365: BoneView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212365
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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