Pde-Neo
510(k) K133719
Pde-Neo is a medical device (FDA Class II; FDA product code IZI, System, X-Ray, Angiographic) made by Hamamatsu Photonics K.K., cleared under FDA 510(k) K133719 on 27 Mar 2014, 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 | FDA 510(k)SESE | NumberK133719 | Date27 Mar 2014 | StatusActive |
Official records
- FDA 510(k) database K133719
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZI
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1600
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K133719
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PDE-GEN3 C13999-40 | C13999-40 | 04582389010871 | — | On the market |
| pde-neo C10935-40 | C10935-40 | 04582389010093 | — | On the market |
| pde-neoII C10935-400 | C10935-400 | 04582389010543 | — | On the market |
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