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

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

28 devices
1–24 of 28
Cleared Sep 11, 2015
CT Sim Laser System
K152303
Gammex, Inc.
Radiology · 28d
Cleared Nov 20, 1997
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
K973162
Hogan & Hartson
General Hospital · 90d
Cleared May 24, 1996
GREEN TEC-2100
K955236
Medtec, Inc.
Radiology · 192d
Cleared Oct 23, 1995
CENTRALITE BACKPOINTER
K954414
Diacor, Inc.
Radiology · 32d
Cleared Aug 18, 1995
TEC-2110 GREEN LASER MODEL MT-HNG
K950293
Medtec, Inc.
Radiology · 205d
Cleared Aug 16, 1995
CENTRALITE(R)-DLL SERIES
K950112
Diacor, Inc.
Radiology · 217d
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
Cleared Oct 08, 1993
AZ 92
K931974
A2j, Inc.
Radiology · 169d
Cleared Jun 04, 1993
PATPOS GREEN
K930294
Cp Bio-Medical Corp.
Radiology · 134d
Cleared May 21, 1993
PATPOS COMPACT
K930295
Cp Bio-Medical Corp.
Radiology · 120d
Cleared May 21, 1993
PATPOS RED
K930296
Cp Bio-Medical Corp.
Radiology · 120d
Cleared Nov 16, 1992
ACCULITE SSL
K923619
Medical Alignment Systems
Radiology · 118d
Cleared Jan 04, 1991
A2J TELEMETER
K904127
A2j, Inc.
Radiology · 128d
Cleared Nov 09, 1990
DIOLASE
K904753
Scanditronix, Inc.
Radiology · 21d
Cleared Aug 17, 1989
CENTRALITE BACKPOINTER
K893398
Diacor, Inc.
Radiology · 108d
Cleared Apr 22, 1988
A2J MZ 44 B TYPE
K880981
A2j, Inc.
Radiology · 45d
Cleared Aug 12, 1987
ACCULITE
K872841
Medical Alignment Systems
Radiology · 23d
Cleared Aug 12, 1987
A2J MZ 44 LASER LIGHT FOR POSITIONING
K872894
Prometex, Inc.
Radiology · 20d
Cleared Jul 15, 1987
CENTRALITE
K872489
Diacor, Inc.
Radiology · 22d

About Product Code IWE - Regulatory Context