THE OBSIDIAN PACS SYSTEM— 510(k) K030635

Substantially Equivalent

Obsidian Medical Technology, Inc.

FDA 510(k) clearance K030635 for THE OBSIDIAN PACS SYSTEM, Substantially Equivalent on 2003-03-28. Applicant: Obsidian Medical Technology, Inc..

Clearance details

Applicant: Obsidian Medical Technology, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2003-02-28
Decision date: 2003-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, 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.