CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0— 510(k) K052537

Substantially Equivalent

American Medical Sales, Inc.

FDA 510(k) clearance K052537 for CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0, Substantially Equivalent on 2005-11-16. Applicant: American Medical Sales, Inc..

Clearance details

Applicant: American Medical Sales, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2005-09-15
Decision date: 2005-11-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hawthorne, CA, US

Download summary PDF View on FDA.gov ↗

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.