MEDICHEART, MODEL RELEASE 1— 510(k) K032823

Substantially Equivalent

Medicsight

FDA 510(k) clearance K032823 for MEDICHEART, MODEL RELEASE 1, Substantially Equivalent on 2003-11-10. Applicant: Medicsight.

Clearance details

Applicant: Medicsight
Product code: Code JAK
Advisory panel: Radiology
Date received: 2003-09-10
Decision date: 2003-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

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.