IWE — Monitor, Patient Position, Light-Beam Class I
FDA product code IWE covers "Monitor, Patient Position, Light-Beam", a Class I medical device regulated under 21 CFR 892.5780. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IWE
- Device Class
- Class I
- Regulation Number
- 892.5780
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K152303 | gammex | CT Sim Laser System | September 11, 2015 |
| K973162 | hogan and hartson | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE | November 20, 1997 |
| K955236 | medtec | GREEN TEC-2100 | May 24, 1996 |
| K954414 | diacor | CENTRALITE BACKPOINTER | October 23, 1995 |
| K950293 | medtec | TEC-2110 GREEN LASER MODEL MT-HNG | August 18, 1995 |
| K950112 | diacor | CENTRALITE(R)-DLL SERIES | August 16, 1995 |
| K951601 | medtec | MED-TEC STRING RETICLE TRAY | May 11, 1995 |
| K943802 | medtec | HP BACK POINTER SYSTEM | December 7, 1994 |
| K943381 | philips medical systems north america | LASER ALIGNMENT TOOL | August 9, 1994 |
| K941169 | medtec | TEC 2101 (MODEL MT-HPLGD) | July 18, 1994 |
| K935760 | medtec | TEC 2100 (MODEL MT-LPLGD) | January 25, 1994 |
| K934519 | medtec | RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM | December 13, 1993 |
| K931974 | a2j | AZ 92 | October 8, 1993 |
| K930294 | cp bio-medical | PATPOS GREEN | June 4, 1993 |
| K930295 | cp bio-medical | PATPOS COMPACT | May 21, 1993 |
| K930296 | cp bio-medical | PATPOS RED | May 21, 1993 |
| K923619 | medical alignment systems | ACCULITE SSL | November 16, 1992 |
| K904127 | a2j | A2J TELEMETER | January 4, 1991 |
| K904753 | scanditronix | DIOLASE | November 9, 1990 |
| K893398 | diacor | CENTRALITE BACKPOINTER | August 17, 1989 |