PRIMELUNG— 510(k) K024149

Substantially Equivalent

Accuimage Diagnostics Corp.

FDA 510(k) clearance K024149 for PRIMELUNG, Substantially Equivalent on 2003-02-21. Applicant: Accuimage Diagnostics Corp..

Clearance details

Applicant: Accuimage Diagnostics Corp.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2002-12-16
Decision date: 2003-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.