510(k) · Cleared
Cleared3D-Anywhere
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Provect.AI · LLZ System, Image Processing, Radiological
Cleared on Jul 9, 2026 as substantially equivalent to K081672 (Mazor Surgical Technologies, Ltd., 2008) after a 216-day review. Its family tree reaches back 5 generations to 2000. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 9, 2026
- Review
- 216 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003266 (2000). 8 ancestors in all. No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 4 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 3 generations backK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
- 2 generations backK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
- 1 generation backK081672 C-InsightMazor Surgical Technologies, Ltd. · 2008
- This deviceK253899 3D-AnywhereProvect.AI · 2026
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System3 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −4 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −3 | K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | 2005 | 4 |
| −2 | K060344 | O-Arm Imaging System | Breakaway Imaging, LLC | 2006 | 1 |
| −1 | K081672 | C-Insight | Mazor Surgical Technologies, Ltd. | 2008 | — |
| 0 (this device) | K253899 | 3D-Anywhere | Provect.AI | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 1 |
| 2004 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K081672 | C-InsightSummary page 5…t and processing system Product Code: QIH CFR 892.2050 Predicate Device: K081672, Mazor Surgical Technologies, Ltd, C-InSight System Classification Name:… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 3 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K081672.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.
The 3D-Anywhere software provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.
It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast anatomical structures, such as bony anatomy, particularly for orthopedic applications.
It is not intended to replace diagnostic imaging modalities (e.g., C-arm, CT or MRI) and is not indicated for procedures involving low contrast tissue or liquid materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253899: 3D-Anywhere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253899
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026