K172307

Substantially Equivalent

Dynamic Coronary Roadmap 2.0

Applicant: Philips Medical Systems Nederland B.V.
Product code: OWB
Advisory panel: Radiology
Date received: 2017-07-31
Decision date: 2017-10-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Best Noord-Brabant, NL

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.