ACTEON SYSTEME PSPIX WIN MAC (Only)
by Sopro
ACTEON SYSTEME PSPIX WIN MAC (Only) (997090) is a Class II device made by Sopro, cleared under FDA 510(k) K151053 on 31 Jul 2015 and listed in FDA GUDID since 19 Nov 2018 (UDI-DI 03760278260434), active as of 23 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 | Number03760278260434 | Date19 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151053 | Date31 Jul 2015 | StatusActive |
Official records
- AccessGUDID record 03760278260434
- FDA 510(k) database K151053
Across registries
- FDA 510(k) K151053 decided 31 Jul 2015 Active
- FDA GUDID UDI-DI 03760278260434 listed 19 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K151053
- Listed FDA GUDID 03760278260434
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acteon
- Generic name
- Dental computed radiography digital imaging scanner
- Model / Ref / Catalog
- SYSTEME PSPIX WIN MAC (Only), 997090
- Primary DI / UDI-DI
- 03760278260434
- 510(k) Number
- FDA product code
- MUH
- GMDN term
- Dental computed radiography digital imaging scanner
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
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