510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964806Substantially Equivalent

Md-1835

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

K964806 is the FDA 510(k) clearance record for MD-1835, a class II device, cleared for Fischer Imaging Corp. on under FDA product code IXL (Device, Spot-Film). FDA records list 69 510(k) clearances for Fischer Imaging Corp., from to . As of , FDA records show no recalls naming K964806.

Clearance record

Decision date
Received
(95 days to decision)
Product code
IXL Device, Spot-Film
Regulation
21 CFR 892.1670
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 IXL

Trailing 12 months

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

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