D²RS and D²RS 9090— 510(k) K221335

Substantially Equivalent

Stephanix

FDA 510(k) clearance K221335 for D²RS and D²RS 9090, Substantially Equivalent on 2022-06-07. Applicant: Stephanix.

Clearance details

Applicant: Stephanix
Product code: Code OWB
Advisory panel: Radiology
Date received: 2022-05-09
Decision date: 2022-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: La Ricamarie, FR

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.