510(k) · Cleared
ClearedSpineanalyer Model Sapoc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optasia Medical · LLZ System, Image Processing, Radiological
Cleared on Jan 5, 2011 as substantially equivalent to K023554 (Ge Lunar Corp., 2002) after a 42-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 5, 2011
- Review
- 42 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950611 (1995). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK950611 Expert Morphomerty SoftwardLunar Corp. · 1995
- 1 generation backK023554 Dual-Energy Vertebral Assessment View SoftwareGe Lunar Corp. · 2002
- This deviceK103475 Spineanalyer Model SapocOptasia Medical · 2011
- Descendant · cites it directly · 0 of its ownK171435 VirtuOst Vertebral Fracture AssessmentO.N. Diagnostics, LLC · 2018
- Descendant · cites it directly · 0 of its ownK120288 Orthocad Software OptionEsaote, S.p.A. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950611 | Expert Morphomerty Softward | Lunar Corp. | 1995 | — |
| −1 | K023554 | Dual-Energy Vertebral Assessment View Software | Ge Lunar Corp. | 2002 | — |
| 0 (this device) | K103475 | Spineanalyer Model Sapoc | Optasia Medical | 2011 | — |
| +1 | K171435 | VirtuOst Vertebral Fracture Assessment | O.N. Diagnostics, LLC | 2018 | — |
| +1 | K120288 | Orthocad Software Option | Esaote, S.p.A. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K023554 | Dual-Energy Vertebral Assessment View SoftwareSummary page 2…Optasia Medical believes that its SpineAnalyzer is substantially equivalent in design, use and materials to the GE LUNAR Dual-energy Vertebral Assessment View Software, K023554. Description of Product The Optasia Medical SpineAnalyzer is a stand-alone software package which can be installed and used on… | 2002 |
What descends from it? (2)
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171435 (O.N. Diagnostics, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K023554.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The Optasia Medical SpineAnalyzer T M is intended for the visualization or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by…
Read the full statement (128 words)
The Optasia Medical SpineAnalyzer T M is intended for the visualization or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by Genant t . Additionally, the qualified medical practitioner can record a manual Genant Semi-Quantitative score based on visual assessment.
The qualified medical practitioner may use the deformity ratios and deformity grades to assist in the diagnosis of vertebral fracture and may, along with knowledge of patient history, apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103475 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103475: Spineanalyer Model Sapoc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103475
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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