510(k) · Cleared
ClearedClearRead CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverain Technologies, LLC · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Sep 9, 2016 as substantially equivalent to K143196 (Siemens AG Medical Solutions, 2015) and 2 other predicates after a 134-day review. Its family tree reaches back 10 generations to 1991. 5 later devices descend from it.
- Decided
- Sep 9, 2016
- Review
- 134 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K913770 (1991). 144 ancestors in all, the oldest K862120 (1986). 5 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK161201 ClearRead CTRiverain Technologies, LLC · 2016
- Descendant · cites it directly · 1 of its ownK192880 InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK254075 Synapse Lung Nodule AIFujifilm Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK240554 InferRead Lung CT.AIInfervision Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242919 V5med Lung AIV5med, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK221612 ClearRead CTRiverain Technologies, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 5 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK161201 ClearRead CTRiverain Technologies, LLC · 2016
Most influential descendants
Showing 5 of 5 · See all- K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd. · 2020 · cites it directly1descendant
- K254075Synapse Lung Nodule AIFujifilm Corporation · 2026 · cites it directly0descendants
- K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K242919V5med Lung AIV5med, Inc. · 2025 · cites it directly0descendants
- K221612ClearRead CTRiverain Technologies, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −5 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| 0 (this device) | K161201 | ClearRead CT | Riverain Technologies, LLC | 2016 | — |
| +1 | K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co., Ltd. | 2020 | — |
| +1 | K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | 2026 | — |
| +2 | K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | 2025 | — |
| +1 | K242919 | V5med Lung AI | V5med, Inc. | 2025 | — |
| +1 | K221612 | ClearRead CT | Riverain Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 8 | 0 |
| 2001 | 15 | 0 |
| 2002 | 11 | 0 |
| 2003 | 5 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 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 OEB? 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 OEB device
- #1 K254075 Synapse Lung Nodule AIscore 14.4 · 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? (3)
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 |
|---|---|---|---|
| * | K143196 | syngo.CT Lung CADSummary page 4…on and is not intended to be used without the original CT series. Predicate Devices: syngo.CT Lung CAD (K143196) Siemens AG Medical Solutions Class II syngo… | 2015 |
| * | K093621 | Syngo.Pet&CT OncologySummary page 4…Siemens AG Medical Solutions Class II syngo.PET&CT Oncology (K093621) Siemens AG Medical Solutions Class II… | 2010 |
| * | K092363 | Softview, Model 2.01Summary page 5…Siemens AG Medical Solutions Class II ClearRead Bone Suppression (SoftView) (K092363) Riverain Technologies, LLC Class II Comparison to Predicate Device… | 2010 |
What descends from it? (5)
4 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 25 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 36 of the 144 ancestors have a recall of any class.
- Of its descendants, K192880 (Beijing Infervision Technology Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K143196.
How does its category compare?
All OEB devicesOEB Lung Computed Tomography System, Computer-Aided Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OEB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OEB
229in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OEB
No recall names OEB since 2007.
Adverse event reports per year · OEB
No MAUDE report names OEB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 229 | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ClearRead CT™ is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest on an asymptomatic population. The ClearRead CT requires both lungs be in the field of view. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161201 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161201: ClearRead CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161201
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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