# K253029: RW-1

- Pathway: 510(k) (Traditional)
- Applicant: Mediott, Inc.
- Decided: Mar 31, 2026 after 193 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 K182431 (2018). 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)
- K212685: Konicaminolta DI-X1, Konica Minolta, Inc. (2021) Summary page 5.

## Indications for use
This software is a medical device intended for the visualization of various intensity modulation including FFT filter. It receives, stores, processes, and displays sequential DICOM images primarily obtained through low-dose chest fluoroscopy (e.g., RF and AX modalities) . This software is not intended to be used for primary diagnosis. Reference images such as scintigraphy or CT scans may be displayed for supplementary purposes. This software is intended for use in adult patients only.

Source page: https://510kreport.com/device/K253029
Methodology: https://510kreport.com/methodology