510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880530Substantially Equivalent

Ceiling Mounted Radiographic System Traumex

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

K880530 is the FDA 510(k) clearance record for CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX, a class I device, cleared for Fischer Imaging Corp. on under FDA product code IYB (Tube Mount, X-Ray, Diagnostic). FDA records list 69 510(k) clearances for Fischer Imaging Corp., from to . As of , FDA records show 2 recalls naming K880530.

Clearance record

Decision date
Received
(23 days to decision)
Product code
IYB Tube Mount, X-Ray, Diagnostic
Regulation
21 CFR 892.1770
Device class
Class I
Review panel
Radiology
Applicant
Fischer Imaging Corp. 12300 N. Grant St., Denver CO
Third party review
No

Clearances, product code IYB

Trailing 12 months

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

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