K092639

Substantially Equivalent

INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP

Applicant: GE Medical Systems SCS
Product code: LLZ
Advisory panel: Radiology
Date received: 2009-08-27
Decision date: 2009-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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.