IIRAD DIRECTRAY OPERATOR CONSOLE— 510(k) K980970

Substantially Equivalent

Sterling Diagnostic Imaging, Inc.

FDA 510(k) clearance K980970 for IIRAD DIRECTRAY OPERATOR CONSOLE, Substantially Equivalent on 1998-06-08. Applicant: Sterling Diagnostic Imaging, Inc..

Clearance details

Applicant: Sterling Diagnostic Imaging, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1998-03-16
Decision date: 1998-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenville, SC, US

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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.