RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR— 510(k) K161345

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K161345 for RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR, Substantially Equivalent on 2016-07-06. Applicant: Sedecal., Sa..

Clearance details

Applicant: Sedecal., Sa.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2016-05-13
Decision date: 2016-07-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Algete, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.