Monitor, Patient Position, Light-Beam
A light-beam patient position monitor is a non-ionizing optical device used in radiation therapy to verify and display the patient's position relative to the treatment field using a projected light beam, aiding accurate setup before radiation delivery. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWE, regulated under 21 CFR 892.5780, within the Radiology medical specialty.
Basic Information
- Product Code
- IWE
- Device Class
- FDA class 1
- Regulation Number
- 892.5780
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 28 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K152303 | CT Sim Laser System | Sep 11, 2015 | Substantially Equivalent | GAMMEX, INC. |
| K973162 | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | Nov 20, 1997 | Substantially Equivalent | HOGAN & HARTSON |
| K955236 | GREEN TEC-2100 | May 24, 1996 | Substantially Equivalent | MEDTEC, INC. |
| K954414 | CENTRALITE BACKPOINTER | Oct 23, 1995 | Substantially Equivalent | DIACOR, INC. |
| K950293 | TEC-2110 GREEN LASER MODEL MT-HNG | Aug 18, 1995 | Substantially Equivalent | MEDTEC, INC. |
| K950112 | CENTRALITE(R)-DLL SERIES | Aug 16, 1995 | Substantially Equivalent | DIACOR, INC. |
| K951601 | MED-TEC STRING RETICLE TRAY | May 11, 1995 | Substantially Equivalent | MEDTEC, INC. |
| K943802 | HP BACK POINTER SYSTEM | Dec 07, 1994 | Substantially Equivalent | MEDTEC, INC. |
| K943381 | LASER ALIGNMENT TOOL | Aug 09, 1994 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
| K941169 | TEC 2101 (MODEL MT-HPLGD) | Jul 18, 1994 | Substantially Equivalent | MEDTEC, INC. |
| K935760 | TEC 2100 (MODEL MT-LPLGD) | Jan 25, 1994 | Substantially Equivalent | MEDTEC, INC. |
| K934519 | RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM | Dec 13, 1993 | Substantially Equivalent | MEDTEC, INC. |
| K931974 | AZ 92 | Oct 08, 1993 | Substantially Equivalent | A2J, INC. |
| K930294 | PATPOS GREEN | Jun 04, 1993 | Substantially Equivalent | CP BIO-MEDICAL CORP. |
| K930296 | PATPOS RED | May 21, 1993 | Substantially Equivalent | CP BIO-MEDICAL CORP. |
| K930295 | PATPOS COMPACT | May 21, 1993 | Substantially Equivalent | CP BIO-MEDICAL CORP. |
| K923619 | ACCULITE SSL | Nov 16, 1992 | Substantially Equivalent | MEDICAL ALIGNMENT SYSTEMS |
| K904127 | A2J TELEMETER | Jan 04, 1991 | Substantially Equivalent | A2J, INC. |
| K904753 | DIOLASE | Nov 09, 1990 | Substantially Equivalent | SCANDITRONIX, INC. |
| K893398 | CENTRALITE BACKPOINTER | Aug 17, 1989 | Substantially Equivalent | DIACOR, INC. |
| K880981 | A2J MZ 44 B TYPE | Apr 22, 1988 | Substantially Equivalent | A2J, INC. |
| K872894 | A2J MZ 44 LASER LIGHT FOR POSITIONING | Aug 12, 1987 | Substantially Equivalent | PROMETEX, INC. |
| K872841 | ACCULITE | Aug 12, 1987 | Substantially Equivalent | MEDICAL ALIGNMENT SYSTEMS |
| K872489 | CENTRALITE | Jul 15, 1987 | Substantially Equivalent | DIACOR, INC. |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | Jul 03, 1986 | Substantially Equivalent | NUCLEAR DIAGNOSTICS, INC. |
| K801541 | WALL MOUNTED LASER POSITIONING DEVICE | Aug 20, 1980 | Substantially Equivalent | ADVANTAGE MEDICAL SYSTEMS, INC. |
| K800489 | LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 | Mar 25, 1980 | Substantially Equivalent | ATC MEDICAL TECHNOLOGY, INC. |
| K800223 | PATIENT POSITIONING SYSTEM 1D OR 2D | Mar 03, 1980 | Substantially Equivalent | LABORATOIRE NATIONAL D'ESSAIS |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.