StatPACS 1000
StatPACS 1000 is a Class II device made by Nucleushealth, LLC, cleared under FDA 510(k) K092134 on 15 Sep 2009 and listed in FDA GUDID since 26 Jul 2024 (UDI-DI 00860257001102), 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 | Number00860257001102 | Date26 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092134 | Date15 Sep 2009 | StatusActive |
Official records
- AccessGUDID record 00860257001102
- FDA 510(k) database K092134
Across registries
- FDA 510(k) K092134 decided 15 Sep 2009 Active
- FDA GUDID UDI-DI 00860257001102 listed 26 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K092134
- Listed FDA GUDID 00860257001102
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- StatPACS
- Generic name
- Diagnostic imaging telemedicine system
- Model / reference
- 1000
- Primary DI / UDI-DI
- 00860257001102
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Diagnostic imaging telemedicine system
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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