Monitor, Patient Position, Light-beam

Product Code: IWE

Radiology Positioning Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 892.5780

• Radiation Type: Optical
• Radition Safety: Product
• Annual Reports: Yes

Products Classified as IWE

5282

Monitor, Patient Position, Light-beam

Light Beam Patient Position Indicator.

Total Product Life Cycle (TPLC) Devices

5282

Monitor, Patient Position, Light-beam

Light Beam Patient Position Indicator.

Pre-market Notifications for IWE

K152303	CT Sim Laser System	GAMMEX, INC.
K973162	DUAL RADIATION TARGETING SYSTEM DRTS DRAPE	HOGAN & HARTSON
K955236	GREEN TEC-2100	MEDTEC, INC.
K954414	CENTRALITE BACKPOINTER	DIACOR, INC.
K951601	MED-TEC STRING RETICLE TRAY	MEDTEC, INC.
K950293	TEC-2110 GREEN LASER MODEL MT-HNG	MEDTEC, INC.
K950112	CENTRALITE(R)-DLL SERIES	DIACOR, INC.
K943802	HP BACK POINTER SYSTEM	MEDTEC, INC.
K943381	LASER ALIGNMENT TOOL	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K941169	TEC 2101 (MODEL MT-HPLGD)	MEDTEC, INC.
K935760	TEC 2100 (MODEL MT-LPLGD)	MEDTEC, INC.
K934519	RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM	MEDTEC, INC.
K931974	AZ 92	A2J, INC.
K930295	PATPOS COMPACT	CP BIO-MEDICAL CORP.
K930296	PATPOS RED	CP BIO-MEDICAL CORP.

Global Unique Device Identification Database

• 04260590370631: Monitor, Patient Position, Light-Beam
• 04260590370624: Monitor, Patient Position, Light-Beam
• 04260590370617: Monitor, Patient Position, Light-Beam
• 04260590370600: Monitor, Patient Position, Light-Beam
• 04260590370594: Monitor, Patient Position, Light-Beam
• 04260590370587: Monitor, Patient Position, Light-Beam
• 04260590370570: Monitor, Patient Position, Light-Beam
• 04260590370556: Monitor, Patient Position, Light-Beam
• 04260590370549: Monitor, Patient Position, Light-Beam
• 04260590370532: Monitor, Patient Position, Light-Beam
• 04260590370525: Monitor, Patient Position, Light-Beam
• 04260590370518: Monitor, Patient Position, Light-Beam
• 04260590370501: Monitor, Patient Position, Light-Beam
• 04260590370488: Monitor, Patient Position, Light-Beam
• 04260590370471: Monitor, Patient Position, Light-Beam

Maude Adverse Events

APOLLOBLUE	LAP LASER GMBH	2018-05-15
ALIGNRT	VISION RT LIMITED	2015-11-19
CENTRAL AXIS MARKER	MEDTEC, INC. (DBA. CIVCO MEDICAL SOLUTIONS)	2009-08-31
REDI-FOAM	MED-TEC,INC.	1998-11-13