510(k) · Cleared
ClearedExcelsior
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Cro, Inc. · NFJ System, Image Management, Ophthalmic
Cleared on Oct 31, 2022 as substantially equivalent to K130453 (Eyekor, LLC, 2013) and 1 other predicate after a 214-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Oct 31, 2022
- Review
- 214 days
- Class
- Class II
- Product code
- NFJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K913770 (1991). 160 ancestors in all, the oldest K870039 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK123577 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2013
- 2 generations backK133644 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2014
- 1 generation backK142647 mint LesionMint Medical GmbH · 2015 · Recalled
- This deviceK220929 ExcelsiorMerit Cro, Inc. · 2022
Show all 14 generations
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 12 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 11 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 10 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 9 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 7 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 5 generations backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- 4 generations backK113029 Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2011
- 3 generations backK123577 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2013
- 2 generations backK133644 Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc. · 2014
- 1 generation backK142647 mint LesionMint Medical GmbH · 2015 · Recalled
- This deviceK220929 ExcelsiorMerit Cro, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −13 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −12 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −11 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −10 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −9 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −7 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −5 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −4 | K113029 | Syngo Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −3 | K123577 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −2 | K133644 | Syngo.Via MI Workflows | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −1 | K142647 | mint Lesion | Mint Medical GmbH | 2015 | 3 |
| 0 (this device) | K220929 | Excelsior | Merit Cro, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 7 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 15 | 0 |
| 2002 | 12 | 0 |
| 2003 | 5 | 0 |
| 2004 | 12 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 NFJ? 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 NFJ device
- #1 K260694 Zeiss Clinic 360score 15.0 · 12 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 |
|---|---|---|---|
| * | K130453 | ExcelsiorSummary page 5…Software, Radiology, 21 C.F.R. §892.2050 Class II Product Codes: NFJ and LLZ Predicate Devices Primary: Merit CRO, Inc. (formerly Eyekor) EXCELSIOR software cleared in K130453 Secondary: Mint Lesion cleared in K142647 Device Description The EXCELSIOR software is a cloud-based software that provides a c… | 2013 |
| * | K142647 | mint LesionSummary page 5…lass II Product Codes: NFJ and LLZ Predicate Devices Primary: Merit CRO, Inc. (formerly Eyekor) EXCELSIOR software cleared in K130453 Secondary: Mint Lesion cleared in K142647 Device Description The EXCELSIOR software is a cloud-based software that provides a central reading platform integrating remote… | 2015 |
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.
- 36 of the 160 ancestors have a recall of any class.
How does its category compare?
All NFJ devicesNFJ System, Image Management, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NFJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NFJ
85in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFJ
2in 2022
MAUDE reports naming product code NFJ, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 67 | 0 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 73 | 0 | 6 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 87 | 1 | 2 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 5 | 175 | 0 | 4 |
| 2018 | 7 | 84 | 0 | 0 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 5 | 116 | 2 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 284 | 1 | 2 |
| 2023 | 4 | 85 | 0 | 0 |
| 2024 | 2 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Ophthalmology The EXCELSIOR Software is intended for use in importing, processing, measurement, and analysis of ophthalmic clinical images as well as in management of clinical data, through a computerized network for use in analysis of images and data obtained in clinical trials. Radiology Excelsior is a software solution intended to be used for viewing, manipulation, communication, annotation, analysis, and comparison of medical images from multiple…
Read the full statement (285 words)
Ophthalmology
The EXCELSIOR Software is intended for use in importing, processing, measurement, and analysis of ophthalmic clinical images as well as in management of clinical data, through a computerized network for use in analysis of images and data obtained in clinical trials.
Radiology
Excelsior is a software solution intended to be used for viewing, manipulation, communication, annotation, analysis, and comparison of medical images from multiple imaging modalities and/or multiple time points. The application supports images, functional data such as PET as well as anatomical datasets, such as CT or MR. Excelsior is a software only medical device to be deployed through a cloud-based computerized network via web applications and customized user interfaces for use in the analysis of images and data obtained in clinical trials. Excelsior enables visualization of information that would otherwise have to be visually compared disjointedly. Excelsior provides analytical and workflow automation tools to help the user assess and document the extent of a disease and/or the response to therapy in accordance with user selected standards and assess changes in imaging findings over multiple time-points. Excelsior supports the interpretation and evaluation of examinations and follow-up documentation of findings for radiologic oncology imaging and data obtained in clinical trials.
The product is intended to be used as a workflow automation tool by trained medical professionals. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings.
Note: The medical professional retains the ultimate responsibility for making the pertinent observations based on their standard practices and established practices related to clinical trial outcomes. Excelsior is a complement to these standard procedures. Excelsior is not to be used in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220929: Excelsior.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220929
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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