510(k) · Cleared
ClearedLessray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saferay Spine, LLC · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 5, 2012 as substantially equivalent to K013841 (3Dsharp, Inc., 2002) after a 51-day review. Its family tree reaches back 1 generation to 2002. 15 later devices descend from it.
- Decided
- Dec 5, 2012
- Review
- 51 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013841 (2002). 15 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013841 3DFIS, Model Ies-FL-1013Dsharp, Inc. · 2002
- This deviceK123226 LessraySaferay Spine, LLC · 2012
- Descendant · cites it directly · 14 of its ownK132970 LessraySaferay Spine, LLC · 2013
- Descendant · cites it directly · 13 of its ownK142243 LessRay with TrackingSaferay Spine, LLC · 2014
- Descendant · 2 generations on · 12 of its ownK170800 NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017
- Descendant · 2 generations on · 4 of its ownK173314 LessRay SystemNu Vasive, Incorporated · 2017
- Descendant · 3 generations on · 3 of its ownK180038 NuVasive Pulse SystemNu Vasive, Incorporated · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K132970LessraySaferay Spine, LLC · 2013 · cites it directly14descendants
- K142243LessRay with TrackingSaferay Spine, LLC · 2014 · cites it directly13descendants
- K170800NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017 · 2 generations on12descendants
- K173314LessRay SystemNu Vasive, Incorporated · 2017 · 2 generations on4descendants
- K180038NuVasive Pulse SystemNu Vasive, Incorporated · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013841 | 3DFIS, Model Ies-FL-101 | 3Dsharp, Inc. | 2002 | — |
| 0 (this device) | K123226 | Lessray | Saferay Spine, LLC | 2012 | — |
| +1 | K132970 | Lessray | Saferay Spine, LLC | 2013 | — |
| +1 | K142243 | LessRay with Tracking | Saferay Spine, LLC | 2014 | — |
| +2 | K170800 | NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated | 2017 | — |
| +2 | K173314 | LessRay System | Nu Vasive, Incorporated | 2017 | — |
| +3 | K180038 | NuVasive Pulse System | Nu Vasive, Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K013841 | 3DFIS, Model Ies-FL-101Summary page 1…Additional Product Code.. LLZ -System, Image Processing, Radiological Predicate Device: K01 3841 3D Sharp Fluoroscope Image System (3DFIS - Model IES-FL- 10l1) Indication for Use: The LessRay… | 2002 |
What descends from it? (15)
See all 152 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?
- Its one ancestor has no recall.
- Of its descendants, K132970 (Saferay Spine, LLC, 2013) has gone furthest, with 14 descendants of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123226: Lessray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123226
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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