MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM— 510(k) K012836

Substantially Equivalent

GE Medical Systems

FDA 510(k) clearance K012836 for MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM, Substantially Equivalent on 2001-09-07. Applicant: GE Medical Systems.

Clearance details

Applicant: GE Medical Systems
Product code: Code JAK
Advisory panel: Radiology
Date received: 2001-08-23
Decision date: 2001-09-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, 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.