IWE · Monitor, Patient Position, Light-Beam
Radiology · 21 CFR 892.5780 · Class 1
Overview
| Product Code | IWE |
|---|---|
| Device Name | Monitor, Patient Position, Light-Beam |
| Regulation | 21 CFR 892.5780 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
Cleared Devices (28)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152303 | CT Sim Laser System | Gammex, Inc. | Sep 11, 2015 | SESE |
| K973162 | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | Hogan & Hartson | Nov 20, 1997 | SESE |
| K955236 | GREEN TEC-2100 | Medtec, Inc. | May 24, 1996 | SESE |
| K954414 | CENTRALITE BACKPOINTER | Diacor, Inc. | Oct 23, 1995 | SESE |
| K950293 | TEC-2110 GREEN LASER MODEL MT-HNG | Medtec, Inc. | Aug 18, 1995 | SESE |
| K950112 | CENTRALITE(R)-DLL SERIES | Diacor, Inc. | Aug 16, 1995 | SESE |
| K951601 | MED-TEC STRING RETICLE TRAY | Medtec, Inc. | May 11, 1995 | SESE |
| K943802 | HP BACK POINTER SYSTEM | Medtec, Inc. | Dec 7, 1994 | SESE |
| K943381 | LASER ALIGNMENT TOOL | Philips Medical Systems North America, Inc. | Aug 9, 1994 | SESE |
| K941169 | TEC 2101 (MODEL MT-HPLGD) | Medtec, Inc. | Jul 18, 1994 | SESE |
| K935760 | TEC 2100 (MODEL MT-LPLGD) | Medtec, Inc. | Jan 25, 1994 | SESE |
| K934519 | RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM | Medtec, Inc. | Dec 13, 1993 | SESE |
| K931974 | AZ 92 | A2j, Inc. | Oct 8, 1993 | SESE |
| K930294 | PATPOS GREEN | Cp Bio-Medical Corp. | Jun 4, 1993 | SESE |
| K930296 | PATPOS RED | Cp Bio-Medical Corp. | May 21, 1993 | SESE |
| K930295 | PATPOS COMPACT | Cp Bio-Medical Corp. | May 21, 1993 | SESE |
| K923619 | ACCULITE SSL | Medical Alignment Systems | Nov 16, 1992 | SESE |
| K904127 | A2J TELEMETER | A2j, Inc. | Jan 4, 1991 | SESE |
| K904753 | DIOLASE | Scanditronix, Inc. | Nov 9, 1990 | SESE |
| K893398 | CENTRALITE BACKPOINTER | Diacor, Inc. | Aug 17, 1989 | SESE |
| K880981 | A2J MZ 44 B TYPE | A2j, Inc. | Apr 22, 1988 | SESE |
| K872894 | A2J MZ 44 LASER LIGHT FOR POSITIONING | Prometex, Inc. | Aug 12, 1987 | SESE |
| K872841 | ACCULITE | Medical Alignment Systems | Aug 12, 1987 | SESE |
| K872489 | CENTRALITE | Diacor, Inc. | Jul 15, 1987 | SESE |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | Nuclear Diagnostics, Inc. | Jul 3, 1986 | SESE |
| K801541 | WALL MOUNTED LASER POSITIONING DEVICE | Advantage Medical Systems, Inc. | Aug 20, 1980 | SESE |
| K800489 | LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 | Atc Medical Technology, Inc. | Mar 25, 1980 | SESE |
| K800223 | PATIENT POSITIONING SYSTEM 1D OR 2D | Laboratoire National D'Essais | Mar 3, 1980 | SESE |
Top Applicants
- Medtec, Inc. — 7 clearances
- Diacor, Inc. — 4 clearances
- Cp Bio-Medical Corp. — 3 clearances
- A2j, Inc. — 3 clearances
- Medical Alignment Systems — 2 clearances
