IWEClass I
Monitor, Patient Position, Light-Beam
21 CFR 892.5780 / Radiology
IWE is the FDA product code for Monitor, Patient Position, Light-Beam, a class I device type, regulated under 21 CFR 892.5780. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 8 recalls.
Classification record
- Product code
- IWE
- Device name
- Monitor, Patient Position, Light-Beam
- Regulation
- 21 CFR 892.5780
- Device class
- Class I
- Review panel
- Radiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 28
- Ingested recalls
- 8
Clearances, product code IWE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 3 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 5 |
| 1994 | 4 |
| 1995 | 4 |
| 1996 | 1 |
| 1997 | 1 |
| 2015 | 1 |
Applicants with the most clearances
Product code IWE| Applicant | Clearances |
|---|---|
| Medtec LLC | 7 |
| Diacor, Inc. | 4 |
| Cp Bio-Medical Corp. | 3 |
| A2j, Inc. | 2 |
| Medical Alignment Systems | 2 |
| A2j, Inc. | 1 |
| Advantage Medical Systems, Inc. | 1 |
| Atc Medical Technology, Inc. | 1 |
| Gammex, Inc. | 1 |
| Hogan & Hartson | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.