IWE · Class I · 21 CFR 892.5780

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

Leading manufacturers include Medtec, Inc. and Philips Medical Systems North America, Inc..

28
Total
28
Cleared
89d
Avg days
1980
Since

FDA 510(k) Cleared Monitor, Patient Position, Light-beam Devices (Product Code IWE)

28 devices
1–24 of 28
Cleared May 24, 1996
GREEN TEC-2100
K955236
Medtec, Inc.
Radiology · 192d
Cleared Aug 18, 1995
TEC-2110 GREEN LASER MODEL MT-HNG
K950293
Medtec, Inc.
Radiology · 205d
Cleared May 11, 1995
MED-TEC STRING RETICLE TRAY
K951601
Medtec, Inc.
Radiology · 34d
Cleared Dec 07, 1994
HP BACK POINTER SYSTEM
K943802
Medtec, Inc.
Radiology · 125d
Cleared Aug 09, 1994
LASER ALIGNMENT TOOL
K943381
Philips Medical Systems North America, Inc.
Radiology · 27d
Cleared Jul 18, 1994
TEC 2101 (MODEL MT-HPLGD)
K941169
Medtec, Inc.
Radiology · 126d
Cleared Jan 25, 1994
TEC 2100 (MODEL MT-LPLGD)
K935760
Medtec, Inc.
Radiology · 60d
Cleared Dec 13, 1993
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM
K934519
Medtec, Inc.
Radiology · 87d

About Product Code IWE - Regulatory Context