IXD · Class I · 21 CFR 892.1400

FDA Product Code IXD: Source, Calibration, Sealed, Nuclear

Leading manufacturers include Amersham Corp. and Syncor Intl. Corp..

2
Total
2
Cleared
48d
Avg days
1981
Since

FDA 510(k) Cleared Source, Calibration, Sealed, Nuclear Devices (Product Code IXD)

2 devices
1–2 of 2
Cleared Mar 26, 1985
FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
K850208
Syncor Intl. Corp.
Radiology · 67d
Cleared Sep 09, 1981
GOLD(AU 195) SPOT MARKER SOURCES
K812235
Amersham Corp.
Radiology · 29d

About Product Code IXD - Regulatory Context