DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR— 510(k) K983392

Name: FDA 510(k) clearance K983392
Creator: U.S. Food and Drug Administration
Published: 1998-12-15

Substantially Equivalent

Data Ray

FDA 510(k) clearance K983392 for DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR, Substantially Equivalent on 1998-12-15. Applicant: Data Ray. Device class: 2.

Clearance details

Applicant: Data Ray
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1998-09-25
Decision date: 1998-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

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Recent devices under product code LLZ

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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.