R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE— 510(k) K050667

Substantially Equivalent

R2 Technology, Inc.

FDA 510(k) clearance K050667 for R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE, Substantially Equivalent on 2005-03-29. Applicant: R2 Technology, Inc..

Clearance details

Applicant: R2 Technology, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2005-03-15
Decision date: 2005-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.