KPT · Class II · 21 CFR 892.1360

FDA Product Code KPT: Calibrator, Dose, Radionuclide

Leading manufacturers include Victoreen, Inc., Mentor Corp. and Capintec, Inc..

32
Total
32
Cleared
97d
Avg days
1977
Since

FDA 510(k) Cleared Calibrator, Dose, Radionuclide Devices (Product Code KPT)

32 devices
1–24 of 32
Cleared Sep 12, 2019
CRC PC Smart Chamber K1
K192199
Capintec, Inc.
Radiology · 30d
Cleared Oct 01, 2002
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
K011493
Mentor Corp.
Radiology · 504d
Cleared Jul 27, 1993
NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
K931657
Victoreen, Inc.
Radiology · 113d
Cleared Aug 21, 1985
RADIOISOTOPE CALIBRATOR MODEL 34-062
K850815
Victoreen, Inc.
Radiology · 174d
Cleared Dec 08, 1981
B.D.A.S.
K813065
General Electric Co.
Radiology · 39d
Cleared Apr 05, 1977
DISPENSER, TECHNETIUM, CLINTICHEM
K770515
Union Carbide Corp.
Radiology · 19d

About Product Code KPT - Regulatory Context