510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K954345Substantially Equivalent

Doosan Dsp 3800 Automatic X-Ray Film Processor

Doosan Corp., Mahwah NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954345 is the FDA 510(k) clearance record for DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR, a class II device, cleared for Doosan Corp. on under FDA product code IXW (Processor, Radiographic-Film, Automatic). FDA records list one 510(k) clearance for Doosan Corp. As of , FDA records show no recalls naming K954345.

Clearance record

Decision date
Received
(30 days to decision)
Product code
IXW Processor, Radiographic-Film, Automatic
Regulation
21 CFR 892.1900
Device class
Class II
Review panel
Radiology
Applicant
Doosan Corp. One Lethbridge Plz., Mahwah NJ
510(k) summary
Summary
Third party review
No

Clearances, product code IXW

Trailing 12 months

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

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