Pde C9830-40
Pde C9830-40 is a surgical microscope fluorescent angiography system (FDA Class II; FDA product code OWN, Confocal Optical Imaging) made by Hamamatsu Photonics K.K., cleared under FDA 510(k) K110480 on 13 Jan 2012 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04582389010031), 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 | Number04582389010031 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110480 | Date13 Jan 2012 | StatusActive |
Official records
- AccessGUDID record 04582389010031
- FDA 510(k) database K110480
Across registries
- FDA 510(k) K110480 decided 13 Jan 2012 Active
- FDA GUDID UDI-DI 04582389010031 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K110480
- Listed FDA GUDID 04582389010031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pde
- Generic name
- Surgical microscope fluorescent angiography system
- Model / reference
- C9830-40
- Primary DI / UDI-DI
- 04582389010031
- 510(k) Number
- FDA product code
- OWN
- GMDN term
- Surgical microscope fluorescent angiography system
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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