ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP— 510(k) K990241

Name: FDA 510(k) clearance K990241
Creator: U.S. Food and Drug Administration
Published: 1999-09-23

Substantially Equivalent

Accuimage Diagnostics Corp.

FDA 510(k) clearance K990241 for ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP, Substantially Equivalent on 1999-09-23. Applicant: Accuimage Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Accuimage Diagnostics Corp.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1999-01-25
Decision date: 1999-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Accuimage Diagnostics Corp.

view all

K024149 — PRIMELUNG2003-02-21
K012106 — ACCUIMAGE SMARTGATE UPGRADE2001-09-25

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.