STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)— 510(k) K092134

Substantially Equivalent

Statrad, LLC

FDA 510(k) clearance K092134 for STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS), Substantially Equivalent on 2009-09-15. Applicant: Statrad, LLC.

Clearance details

Applicant: Statrad, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-07-15
Decision date: 2009-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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.