510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091517Substantially Equivalent

Ralco, Model R225 Acs

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

K091517 is the FDA 510(k) clearance record for RALCO, MODEL R225 ACS, a class II device, cleared for Ralco S.R.L. on under FDA product code IZW (Collimator, Automatic, Radiographic). FDA records list 2 510(k) clearances for Ralco S.R.L., from to . As of , FDA records show no recalls naming K091517.

Clearance record

Decision date
Received
(53 days to decision)
Product code
IZW Collimator, Automatic, Radiographic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Applicant
Ralco S.R.L. 333 Milford Rd., Deerfield IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZW

Trailing 12 months

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

FDA records show no clearances under product code IZW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZW, 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