DeviceClearance

REMEX-T(K)100C— 510(k) K261943

Substantially Equivalent

Remedi, Inc.

FDA 510(k) clearance K261943 for REMEX-T(K)100C, Substantially Equivalent on 2026-10-02. Applicant: Remedi, Inc.. Device class: 2.

Summary

REMEX-T(K)100C from Remedi is filed under IZL, mobile x-ray systems. The record doesn't give specifications beyond the model name.

Class II, 21 CFR 892.1720. The Radiology panel reviewed it as a Traditional 510(k).

Remedi filed from Seoul, South Korea. Review took 114 days (June 10 to October 2, 2026).

Clearance details

Applicant
Remedi, Inc.
Product code
Product code IZL
Device class
Class 2
Regulation
21 CFR 892.1720
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seoul, KR
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IZL

product code IZL
Other
3
Total
3

Source: openFDA MAUDE database, through . 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.