510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812235Substantially Equivalent

Gold(au 195) Spot Marker Sources

Amersham Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812235 is the FDA 510(k) clearance record for GOLD(AU 195) SPOT MARKER SOURCES, a class I device, cleared for Amersham Corp. on under FDA product code IXD (Source, Calibration, Sealed, Nuclear). FDA records list 94 510(k) clearances for Amersham Corp., from to . As of , FDA records show no recalls naming K812235.

Clearance record

Decision date
Received
(29 days to decision)
Product code
IXD Source, Calibration, Sealed, Nuclear
Regulation
21 CFR 892.1400
Device class
Class I
Review panel
Radiology
Applicant
Amersham Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IXD

Trailing 12 months

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

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