MITS DICOM GATEWAY AND IMAGE MANAGER— 510(k) K092581

Substantially Equivalent

Mitsmed Medical Instrument Technology Co., Ltd.

FDA 510(k) clearance K092581 for MITS DICOM GATEWAY AND IMAGE MANAGER, Substantially Equivalent on 2009-10-30. Applicant: Mitsmed Medical Instrument Technology Co., Ltd..

Clearance details

Applicant: Mitsmed Medical Instrument Technology Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-08-21
Decision date: 2009-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

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.