510(k) · Cleared
ClearedVirtuOst Vertebral Fracture Assessment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O.N. Diagnostics, LLC · LLZ System, Image Processing, Radiological
Cleared on Aug 3, 2018 as substantially equivalent to K103475 (Optasia Medical, 2011) and 1 other predicate after a 445-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 3, 2018
- Review
- 445 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950611 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK950611 Expert Morphomerty SoftwardLunar Corp. · 1995
- 2 generations backK023554 Dual-Energy Vertebral Assessment View SoftwareGe Lunar Corp. · 2002
- 1 generation backK103475 Spineanalyer Model SapocOptasia Medical · 2011
- This deviceK171435 VirtuOst Vertebral Fracture AssessmentO.N. Diagnostics, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950611 | Expert Morphomerty Softward | Lunar Corp. | 1995 | — |
| −2 | K023554 | Dual-Energy Vertebral Assessment View Software | Ge Lunar Corp. | 2002 | — |
| −1 | K103475 | Spineanalyer Model Sapoc | Optasia Medical | 2011 | — |
| 0 (this device) | K171435 | VirtuOst Vertebral Fracture Assessment | O.N. Diagnostics, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K103475 | Spineanalyer Model SapocSummary page 4…Bone Densitometer Secondary Regulation Number: 21 CFR 892.1170 Secondary Product Code: KGI 3) Identification of Predicate Devices K103475: SpineAnalyzer Company: Optasia Medical Primary Classification N… | 2011 |
| * | K023554 | Dual-Energy Vertebral Assessment View SoftwareSummary page 4…ation Name: Picture archiving and communications system Primary Regulation Number: 21 CFR 892.2050 Primary Product Code: LLZ K023554: Dual-Energy Vertebral Assessment View Software Option Company: GE L… | 2002 |
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 23 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K103475.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171435: VirtuOst Vertebral Fracture Assessment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171435
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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