DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION— 510(k) K033244

Substantially Equivalent

Ge Medical Systems, Inc.

FDA 510(k) clearance K033244 for DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION, Substantially Equivalent on 2003-10-16. Applicant: Ge Medical Systems, Inc..

Clearance details

Applicant: Ge Medical Systems, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2003-10-07
Decision date: 2003-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.