# K240724: SynthVISION 1.0.0

- Pathway: 510(k) (Traditional)
- Applicant: Synthesis Health Intelligence, Inc.
- Decided: Aug 8, 2024 after 143 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 2 generations back to K161515 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172490: eUnity, Client Outlook, Inc. (2018) Summary page 4.

## Indications for use
SynthVISION is a software application that can be used within a web -browser to process and view DICOM and non-DICOM image data and associated medical information to aid in the day-to-day diagnostic activities of medical imaging professionals and those involved in the care of a patient. SynthVISION displays both lossy-compressed and lossless images. Lossy compressed images are always clearly labeled with the type and degree of data compression. The user must determine if the degree of lossy compression is acceptable for their purposes. Prior to making any medical decisions, the user must view the images within the user’s scope of practice. SynthVISION allows for 2D, multi-planar reformatted and 3D image display and manipulation of medical images, including rotation, measurement, annotation, zoom, window width/level and a variety of other standard tools that a user might need to aid in their diagnostic work. Any display devices must adhere to applicable regulatory standards. Mobile use for mammography is only for reference and referrals. SynthVISION utilizes modern authorization and authentication mechanisms that enforce secure access for permissioned users who view the imaging data. The system extends beyond the hospital/clinic/health care provider and its internal network. With proper authorization, SynthVISION can be accessed by users outside of the provider's internal network. SynthVISION does not contact the patient. Limitations: Worklists, reporting information, image storage, image transmission, users, roles, and permissions are provided via connectivity to other information systems such as EMRs, Radiology Information Systems, Cardiology Information Systems, and Lab Information Systems and are not a part of the viewer.

Source page: https://510kreport.com/device/K240724
Methodology: https://510kreport.com/methodology