LIFESYS PACS— 510(k) K161341

Substantially Equivalent

Lifetrack Medical Systems, Inc.

FDA 510(k) clearance K161341 for LIFESYS PACS, Substantially Equivalent on 2017-04-05. Applicant: Lifetrack Medical Systems, Inc..

Clearance details

Applicant: Lifetrack Medical Systems, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-05-13
Decision date: 2017-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taguig City, PH

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.