# K220929: Excelsior

- Pathway: 510(k) (Traditional)
- Applicant: Merit Cro, Inc.
- Decided: Oct 31, 2022 after 214 days
- Product code: NFJ (System, Image Management, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K913770 (1991). 160 ancestors in all.
No later device cites it as a predicate yet.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130453: Excelsior, Eyekor, LLC (2013) Summary page 5.
- K142647: mint Lesion, Mint Medical GmbH (2015) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K220929
Methodology: https://510kreport.com/methodology