FDR SE Lite
510(k) K192440
FDR SE Lite is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K192440 on 1 Nov 2019, 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 | NumberK192440 | Date1 Nov 2019 | StatusActive |
Official records
- FDA 510(k) database K192440
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192440
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 | |||
|---|---|---|---|---|
| FDR SE Console DR-ID330CL | DR-ID330CL | 04547410414530 | — | On the market |
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