RamSoft 6.0.11.11031B
RamSoft 6.0.11.11031B (PSPACS6PRU11B) is a Class II device made by Ramsoft Inc, cleared under FDA 510(k) K052460 on 21 Sep 2005 and listed in FDA GUDID since 9 Sep 2024 (UDI-DI B359PSPACS6PRU11B0), 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 | NumberB359PSPACS6PRU11B0 | Date9 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK052460 | Date21 Sep 2005 | StatusActive |
Official records
- FDA 510(k) database K052460
Across registries
- FDA 510(k) K052460 decided 21 Sep 2005 Active
- FDA GUDID UDI-DI B359PSPACS6PRU11B0 listed 9 Sep 2024 Listed
Timeline
- Cleared FDA 510(k) K052460
- Listed FDA GUDID B359PSPACS6PRU11B0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RamSoft
- Generic name
- Radiology information system
- Model / Ref / Catalog
- 6.0.11.11031B, PSPACS6PRU11B
- Primary DI / UDI-DI
- B359PSPACS6PRU11B0
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology information system
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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