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
K110856Substantially Equivalent

Ralco

Ralco S.r.l., Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110856 is the FDA 510(k) clearance record for RALCO, a class II device, cleared for Ralco S.R.L. on under FDA product code IZX (Collimator, Manual, Radiographic). FDA records list one 510(k) clearance for Ralco S.R.L. As of , FDA records show no recalls naming K110856.

Clearance record

Decision date
Received
(135 days to decision)
Product code
IZX Collimator, Manual, Radiographic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Applicant
Ralco S.R.L. 8870 Ravello Ct., Naples FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZX

Trailing 12 months

FDA records hold no clearances under product code IZX in the trailing twelve months.

FDA records show no clearances under product code IZX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260