510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893674Substantially Equivalent

Rme 325R

Fischer Imaging Corp., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893674 is the FDA 510(k) clearance record for RME 325R, a class I device, cleared for Fischer Imaging Corp. on under FDA product code IZO (Generator, High-Voltage, X-Ray, Diagnostic). FDA records list 69 510(k) clearances for Fischer Imaging Corp., from to . As of , FDA records show no recalls naming K893674.

Clearance record

Decision date
Received
(66 days to decision)
Product code
IZO Generator, High-Voltage, X-Ray, Diagnostic
Regulation
21 CFR 892.1700
Device class
Class I
Review panel
Radiology
Applicant
Fischer Imaging Corp. 12300 N. Grant St., Denver CO
Third party review
No

Clearances, product code IZO

Trailing 12 months

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

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