DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Sedecal., Sa.
Product code
Code IZL
Device class
Class 2
Regulation
21 CFR 892.1720
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Algete, ES
Download summary PDFView on FDA.gov ↗

Recent devices under product code IZL

view all

More clearances from Sedecal., Sa.

view all

Adverse events under product code IZL

product code IZL
Other
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K161345

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161345.

Data sourced from openFDA. This site is unofficial and independent of the FDA.