AccessNET 7
by Aspyra, LLC.
AccessNET 7 is a Class II device made by Aspyra, LLC., cleared under FDA 510(k) K091631 on 18 Mar 2010 and listed in FDA GUDID since 29 Sep 2016 (UDI-DI B433AN0), 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 | NumberB433AN0 | Date29 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK091631 | Date18 Mar 2010 | StatusActive |
Official records
- FDA 510(k) database K091631
Across registries
- FDA 510(k) K091631 decided 18 Mar 2010 Active
- FDA GUDID UDI-DI B433AN0 listed 29 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K091631
- Listed FDA GUDID B433AN0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AccessNET
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- 7
- Primary DI / UDI-DI
- B433AN0
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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