IWE · Class I · 21 CFR 892.5780

FDA Product Code IWE: Monitor, Patient Position, Light-beam

Leading manufacturers include Medtec, Inc., Diacor, Inc. and A2j, Inc..

28
Total
28
Cleared
89d
Avg days
1980
Since
28 devices
25–28 of 28
Cleared Jul 03, 1986
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
K860472
Nuclear Diagnostics, Inc.
Radiology · 147d
Cleared Aug 20, 1980
WALL MOUNTED LASER POSITIONING DEVICE
K801541
Advantage Medical Systems, Inc.
Radiology · 48d
Cleared Mar 25, 1980
LASER BACKPOINTER ASSEMBLY, MOD. 01-2487
K800489
Atc Medical Technology, Inc.
Radiology · 21d
Cleared Mar 03, 1980
PATIENT POSITIONING SYSTEM 1D OR 2D
K800223
Laboratoire National D'Essais
Radiology · 28d