510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K912741Substantially Equivalent

Elite R 90/15

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

K912741 is the FDA 510(k) clearance record for ELITE R 90/15, a class II device, cleared for Fischer Imaging Corp. on under FDA product code IXR (Table, Radiographic, Tilting). FDA records list 69 510(k) clearances for Fischer Imaging Corp., from to . As of , FDA records show no recalls naming K912741.

Clearance record

Decision date
Received
(105 days to decision)
Product code
IXR Table, Radiographic, Tilting
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Fischer Imaging Corp. 2301 Windsor Ct., Addison IL
510(k) summary
Statement
Third party review
No

Clearances, product code IXR

Trailing 12 months

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

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