INNOVA 4100, INNOVA 3100— 510(k) K042053

Substantially Equivalent

Ge Medical Systems, Inc.

FDA 510(k) clearance K042053 for INNOVA 4100, INNOVA 3100, Substantially Equivalent on 2004-08-26. Applicant: Ge Medical Systems, Inc..

Clearance details

Applicant: Ge Medical Systems, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2004-07-30
Decision date: 2004-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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.