RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

System, X-ray, Mobile

SEDECAL SA

The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Radpro® Mobile 40kw; Radpro® Mobile 40kw Flexplus, Model Sm-40hf-b-d-vir.

Pre-market Notification Details

• Device ID: K161345
• 510k Number: K161345
• Device Name: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
• Classification: System, X-ray, Mobile
• Applicant: SEDECAL SA PELAYA, 9 POL.; POL. IND. "RIO DE JANEIRO" Algete, ES 28110
• Contact: Ma Luisa Gomez De Aguero
• Correspondent: Daniel Kamm; Kamm & Associates 8870 Ravello Ct Naples, FL 34114
• Product Code: IZL
• CFR Regulation Number: 892.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-05-13
• Decision Date: 2016-07-06
• Summary: summary