SCS
- Product code
- SCS
- Device name
- Ultraviolet Radiation Disinfection Chamber Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.6511
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251354 | 2026-01-29 | UV Smart Technologies B.V. | UV Smart D60 | |
| DEN230067 | 2024-08-28 | Germitec | Chronos® | — |
Official FDA classification page: SCS
Classification and pathway per current FDA publications. Data from openFDA (CC0).