eRAD RIS 3.18
by Erad, Inc.
eRAD RIS 3.18 is a Class II device made by Erad, Inc., cleared under FDA 510(k) K120995 on 3 Dec 2012 and listed in FDA GUDID since 1 Jan 2018 (UDI-DI 00866994000248), 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 | GUDID listing | Number00866994000248 | Date1 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120995 | Date3 Dec 2012 | StatusActive |
Official records
- AccessGUDID record 00866994000248
- FDA 510(k) database K120995
Across registries
- FDA 510(k) K120995 decided 3 Dec 2012 Active
- FDA GUDID UDI-DI 00866994000248 listed 1 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K120995
- Listed FDA GUDID 00866994000248
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- eRAD RIS
- Generic name
- Radiology information system application software
- Model / reference
- 3.18
- Primary DI / UDI-DI
- 00866994000248
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology information system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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