VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400— 510(k) K861698

Substantially Equivalent

Visiscan

FDA 510(k) clearance K861698 for VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400, Substantially Equivalent on 1986-10-03. Applicant: Visiscan.

Clearance details

Applicant: Visiscan
Product code: Code JAK
Advisory panel: Radiology
Date received: 1986-05-05
Decision date: 1986-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, 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.