Digital Expert Access 1
Digital Expert Access 1 is a Class II device made by GE Healthcare, cleared under FDA 510(k) K150193 on 24 Mar 2015 and listed in FDA GUDID since 7 Apr 2021 (UDI-DI 00195278263919), 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 | Number00195278263919 | Date7 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150193 | Date24 Mar 2015 | StatusActive |
Official records
- AccessGUDID record 00195278263919
- FDA 510(k) database K150193
Across registries
- FDA 510(k) K150193 decided 24 Mar 2015 Active
- FDA GUDID UDI-DI 00195278263919 listed 7 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K150193
- Listed FDA GUDID 00195278263919
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Digital Expert Access
- Generic name
- Diagnostic x-ray digital imaging system workstation
- Model / reference
- 1
- Primary DI / UDI-DI
- 00195278263919
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Diagnostic x-ray digital imaging system workstation
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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