510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K161345Substantially Equivalent

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

Sedecal S.A., Algete, ES / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161345 is the FDA 510(k) clearance record for RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR, a class II device, cleared for Sedecal., Sa. on under FDA product code IZL (System, X-Ray, Mobile). FDA records list 26 510(k) clearances for Sedecal., Sa., from to . As of , FDA records show 13 recalls naming K161345.

Clearance record

Decision date
Received
(54 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Sedecal., Sa. Pelaya, 9 Pol.; Pol. Ind., Algete, ES
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZL

Trailing 12 months
6 clearances under product code IZL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20260