CT GUIDE (TM)— 510(k) K903622

Substantially Equivalent

Radi Medical Systems AB

FDA 510(k) clearance K903622 for CT GUIDE (TM), Substantially Equivalent on 1990-10-29. Applicant: Radi Medical Systems AB.

Clearance details

Applicant: Radi Medical Systems AB
Product code: Code JAK
Advisory panel: Radiology
Date received: 1990-08-09
Decision date: 1990-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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.