510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904182Substantially Equivalent

R-800-Sf

Advantech Corporation, Wakefield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904182 is the FDA 510(k) clearance record for R-800-SF, a class I device, cleared for Advantech on under FDA product code ITY (Assembly, Tube Housing, X-Ray, Diagnostic). FDA records list 3 510(k) clearances for Advantech, from to . As of , FDA records show no recalls naming K904182.

Clearance record

Decision date
Received
(63 days to decision)
Product code
ITY Assembly, Tube Housing, X-Ray, Diagnostic
Regulation
21 CFR 892.1760
Device class
Class I
Review panel
Radiology
Applicant
Advantech 16 Lawrence St., Wakefield MA
Third party review
No

Clearances, product code ITY

Trailing 12 months

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

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