510(k) · Cleared
ClearedSOTA Cloud Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sota Precision Optics, Inc. Dba Sota Imaging · LLZ System, Image Processing, Radiological
Cleared on May 4, 2021 as substantially equivalent to K132342 (Apteryx, Inc., 2013) after a 57-day review. Its family tree reaches back 8 generations to 1991. 1 later device descends from it.
- Decided
- May 4, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913770 (1991). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 4 generations backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 3 generations backK083018 Centricity Pacs Web DiagnosticGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- 2 generations backK112974 Picture Archiving and Communications SystemCurve Dental, Inc. · 2011
- 1 generation backK132342 XVWEBApteryx, Inc. · 2013
- This deviceK210682 SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging · 2021
- Descendant · cites it directly · 0 of its ownK253111 Aeka ImagingGood Methods Global, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253111Aeka ImagingGood Methods Global, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −4 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| −3 | K083018 | Centricity Pacs Web Diagnostic | Ge Healthcare Dynamic Imaging Solutions | 2008 | 4 |
| −2 | K112974 | Picture Archiving and Communications System | Curve Dental, Inc. | 2011 | — |
| −1 | K132342 | XVWEB | Apteryx, Inc. | 2013 | — |
| 0 (this device) | K210682 | SOTA Cloud Imaging | Sota Precision Optics, Inc. Dba Sota Imaging | 2021 | — |
| +1 | K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K132342 | XVWEBSummary page 5…rator/Manufacturer: Apertyx, Inc. SOTA Cloud Imaging 1 of 13 April 30, 2021 510(k) Premarket Notification Number: K1 32342 Trade Name: XV Web Common Name: Dental imaging software Classification Name: Medical Image Management and Processing System Produ… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253111 | Aeka Imaging | 2026 | 0 |
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 30 years and passes through 8 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K253111 (Good Methods Global, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132342.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime sensors and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data. SOTA Cloud Imaging is intended to acquire, display, process, edit (e.g., resize, adjust…
Read the full statement (110 words)
SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime sensors and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data.
SOTA Cloud Imaging is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware. SOTA Cloud Imaging is also intended for use for diagnostic and non-diagnostic purposes in the field of Dentistry by dental professionals who are responsible for providing dental care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210682: SOTA Cloud Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210682
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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