GUIDEMIA— 510(k) K121466

Name: FDA 510(k) clearance K121466
Creator: U.S. Food and Drug Administration
Published: 2012-05-31

Substantially Equivalent

Guidemia Technologies, LLC

FDA 510(k) clearance K121466 for GUIDEMIA, Substantially Equivalent on 2012-05-31. Applicant: Guidemia Technologies, LLC. Device class: 2.

Clearance details

Applicant: Guidemia Technologies, LLC
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2012-05-17
Decision date: 2012-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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K162850 — GuideMia Ortho+2017-03-24

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.