RW-1— 510(k) K253029

Name: FDA 510(k) clearance K253029
Creator: U.S. Food and Drug Administration
Published: 2026-03-31

Substantially Equivalent

Mediott, Inc.

FDA 510(k) clearance K253029 for RW-1, Substantially Equivalent on 2026-03-31. Applicant: Mediott, Inc.. Device class: 2.

Summary

Mediott's RW-1 is filed under LLZ, radiological image processing systems. The record doesn't describe the device beyond that short name and the code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Mediott filed from Shinjuku-Ku, Japan. Review took 193 calendar days (September 19, 2025 to March 31, 2026).

Clearance details

Applicant: Mediott, Inc.
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-09-19
Decision date: 2026-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shinjuku-Ku, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

K263648 — Vitrea Advanced Visualization, Version 7.162026-10-29
K261763 — MIM KineticID2026-10-26
K261531 — PV-iCurve Pro2026-10-21
K261788 — Eden PACS2026-10-21
K263048 — Syngo Carbon Space (VA4)2026-09-29

More clearances from Mediott, Inc.

view all

K232456 — RW-12025-08-11

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.