FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM— 510(k) K003837

Substantially Equivalent

Ge Oec Medical Systems

FDA 510(k) clearance K003837 for FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM, Substantially Equivalent on 2001-03-12. Applicant: Ge Oec Medical Systems.

Clearance details

Applicant: Ge Oec Medical Systems
Product code: Code OXO
Advisory panel: Radiology
Date received: 2000-12-12
Decision date: 2001-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.