Infinitt RT PACS— 510(k) K193498

Substantially Equivalent

Infinitt Healthcare Co., Ltd.

FDA 510(k) clearance K193498 for Infinitt RT PACS, Substantially Equivalent on 2020-02-13. Applicant: Infinitt Healthcare Co., Ltd..

Clearance details

Applicant: Infinitt Healthcare Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-12-17
Decision date: 2020-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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.