PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)— 510(k) K082964

Substantially Equivalent

Prism Clinical Imaging, Inc.

FDA 510(k) clearance K082964 for PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5), Substantially Equivalent on 2009-03-09. Applicant: Prism Clinical Imaging, Inc..

Clearance details

Applicant: Prism Clinical Imaging, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2008-10-03
Decision date: 2009-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Allis, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.