RSM 1824C with RConsole1— 510(k) K162670

Substantially Equivalent

DRTECH Corporation

FDA 510(k) clearance K162670 for RSM 1824C with RConsole1, Substantially Equivalent on 2017-02-23. Applicant: DRTECH Corporation.

Clearance details

Applicant: DRTECH Corporation
Product code: Code MUE
Advisory panel: Radiology
Date received: 2016-09-26
Decision date: 2017-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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.