510(k) · Cleared
ClearedClearRead CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverain Technologies, Inc. · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Dec 5, 2022 as substantially equivalent to K161201 (Riverain Technologies, LLC, 2016) and 1 other predicate after a 185-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Dec 5, 2022
- Review
- 185 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913770 (1991). 164 ancestors in all, the oldest K862120 (1986). No later device cites it as a predicate yet.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 1 generation backK161201 ClearRead CTRiverain Technologies, LLC · 2016
- This deviceK221612 ClearRead CTRiverain Technologies, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 9 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 8 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 7 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 6 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 4 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 1 generation backK161201 ClearRead CTRiverain Technologies, LLC · 2016
- This deviceK221612 ClearRead CTRiverain Technologies, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −9 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −8 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −7 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −6 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −4 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −1 | K161201 | ClearRead CT | Riverain Technologies, LLC | 2016 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 8 | 0 |
| 1998 | 13 | 0 |
| 1999 | 6 | 0 |
| 2000 | 9 | 0 |
| 2001 | 18 | 0 |
| 2002 | 13 | 0 |
| 2003 | 7 | 0 |
| 2004 | 14 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K161201 | ClearRead CTSummary page 5…r DICOM media. ClearRead CT Compare is a product extension of our FDA cleared and marketed ClearRead CT device (K161201). The initial device contained ClearRead CT Vessel Suppress as well as… | 2016 |
| * | K162484 | Lung Nodule Assessment and Comparison Option (LNA)Summary page 5…Class II 21 CFR §892.2050 Secondary Predicate Device: Philips Medical Systems Nederland B.V. (K162484) Lung Nodule Assessment and Comparison Option (LNA) Traditional 510(k) Premarket Noti… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 42 of the 164 ancestors have a recall of any class.
- 3 other devices also cite its predicate K161201.
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. 2022, 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 and characterization of pulmonary nodules during the review of screening and surveillance (low-dose) CT examinations of the chest on a non-oncological patient population. ClearRead CT requires both lungs be in the field of view and is not intended for monitoring patients undergoing therapy for lung cancer or limited field of view CT scans. 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/K221612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221612: ClearRead CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221612
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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