Atlas FDA

IWE

28 FDA 510(k) clearances · Product code

90 daysmedian time to decision
192 days90th percentile
28clearances measured

FDA profile

Official device name
Monitor, Patient Position, Light-Beam
Device class
Class I (low risk)
Regulation
21 CFR 892.5780
Medical specialty
Radiology
Adverse events (MAUDE)
1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CT Sim Laser System (K152303)Gammex, Inc.2015-09-11
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (K973162)Hogan & Hartson1997-11-20
GREEN TEC-2100 (K955236)Medtec, Inc.1996-05-24
CENTRALITE BACKPOINTER (K954414)Diacor, Inc.1995-10-23
TEC-2110 GREEN LASER MODEL MT-HNG (K950293)Medtec, Inc.1995-08-18
CENTRALITE(R)-DLL SERIES (K950112)Diacor, Inc.1995-08-16
MED-TEC STRING RETICLE TRAY (K951601)Medtec, Inc.1995-05-11
HP BACK POINTER SYSTEM (K943802)Medtec, Inc.1994-12-07
LASER ALIGNMENT TOOL (K943381)Philips Medical Systems North America, Inc.1994-08-09
TEC 2101 (MODEL MT-HPLGD) (K941169)Medtec, Inc.1994-07-18
TEC 2100 (MODEL MT-LPLGD) (K935760)Medtec, Inc.1994-01-25
RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM (K934519)Medtec, Inc.1993-12-13
AZ 92 (K931974)A2j, Inc.1993-10-08
PATPOS GREEN (K930294)Cp Bio-Medical Corp.1993-06-04
PATPOS COMPACT (K930295)Cp Bio-Medical Corp.1993-05-21
PATPOS RED (K930296)Cp Bio-Medical Corp.1993-05-21
ACCULITE SSL (K923619)Medical Alignment Systems1992-11-16
A2J TELEMETER (K904127)A2j, Inc.1991-01-04
DIOLASE (K904753)Scanditronix, Inc.1990-11-09
CENTRALITE BACKPOINTER (K893398)Diacor, Inc.1989-08-17
A2J MZ 44 B TYPE (K880981)A2j, Inc.1988-04-22
ACCULITE (K872841)Medical Alignment Systems1987-08-12
A2J MZ 44 LASER LIGHT FOR POSITIONING (K872894)Prometex, Inc.1987-08-12
CENTRALITE (K872489)Diacor, Inc.1987-07-15
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS (K860472)Nuclear Diagnostics, Inc.1986-07-03
WALL MOUNTED LASER POSITIONING DEVICE (K801541)Advantage Medical Systems, Inc.1980-08-20
LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 (K800489)Atc Medical Technology, Inc.1980-03-25
PATIENT POSITIONING SYSTEM 1D OR 2D (K800223)Laboratoire National D'Essais1980-03-03

Track IWE automatically

Every clearance here is in the API, with alerts when new ones post.