CT MIDLINE— 510(k) K141151

Substantially Equivalent

Medcomp (Medical Components, Inc.)

FDA 510(k) clearance K141151 for CT MIDLINE, Substantially Equivalent on 2014-07-08. Applicant: Medcomp (Medical Components, Inc.).

Clearance details

Applicant: Medcomp (Medical Components, Inc.)
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2014-05-05
Decision date: 2014-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.