# K260936: RadioViewAI

- Pathway: 510(k) (Traditional)
- Applicant: Neurocareai, Inc. (Dba Savelife.Ai)
- Decided: Jul 31, 2026 after 133 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: 9 generations back to K942120 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232891: Carpl (Carpl), Carpl Ai, Inc. (2024) Summary page 5.

## Indications for use
RadioViewAI is a web-based PACS and image management software, used for viewing and assessing multi modality DICOM images Ex: DX, DR, CR, CT, MR, US, RF, XA, XR, NM, PT, and 2D/3D mammography. It gathers digital images and information from a variety of sources adhering to DICOM standard, including PACS systems, digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, PET units, secondary capture tools and imaging gateways. RadioViewAI facilitates transmission, storage, processing and visualization of DICOM images and data within the system itself or over computer networks spanning different locations. Lossy compressed mammographic images and digitized film screen images as received from hospitals must be reviewed for reference purposes only, not for primary diagnostic interpretation on the RadioViewAI. To ensure quality, DICOM images should only be viewed on a monitor that adheres to the technical specifications outlined by the FDA. The software shall only be used by proficient and certified medical experts, including physicians, radiologists, and medical technicians.

Source page: https://510kreport.com/device/K260936
Methodology: https://510kreport.com/methodology