Acteon Imaging Suite (Dvd):
Acteon Imaging Suite (Dvd): (990263) is a Class II device made by De Götzen SRL, cleared under FDA 510(k) K192165 on 11 Feb 2020 and listed in FDA GUDID since 8 Apr 2020 (UDI-DI D8049902630), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD8049902630 | Date8 Apr 2020 | StatusListed |
| United States | FDA 510(k) | NumberK192165 | Date11 Feb 2020 | StatusActive |
Official records
- FDA 510(k) database K192165
Across registries
- FDA 510(k) K192165 decided 11 Feb 2020 Active
- FDA GUDID UDI-DI D8049902630 listed 8 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K192165
- Listed FDA GUDID D8049902630
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acteon Imaging Suite
- Generic name
- Panoramic/tomographic dental x-ray system application software
- Model / Ref / Catalog
- ACTEON IMAGING SUITE (DVD):, 990263
- Primary DI / UDI-DI
- D8049902630
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Panoramic/tomographic dental x-ray system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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