Tablet computer + Pre-installed Software ACC00001
Tablet computer + Pre-installed Software ACC00001 is a multi-purpose stereotactic surgery system (FDA Class II; FDA product code SBF, Orthopedic Augmented Reality) made by Augmedics Ltd., cleared under FDA 510(k) K190929 on 20 Dec 2019 and listed in FDA GUDID since 16 Mar 2020 (UDI-DI 07290113780262), 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 | Number07290113780262 | Date16 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190929 | Date20 Dec 2019 | StatusActive |
Official records
- AccessGUDID record 07290113780262
- FDA 510(k) database K190929
Across registries
- FDA 510(k) K190929 decided 20 Dec 2019 Active
- FDA GUDID UDI-DI 07290113780262 listed 16 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K190929
- Listed FDA GUDID 07290113780262
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tablet computer + Pre-installed Software
- Generic name
- Multi-purpose stereotactic surgery system
- Model / reference
- ACC00001
- Primary DI / UDI-DI
- 07290113780262
- 510(k) Number
- FDA product code
- SBF
- GMDN term
- Multi-purpose stereotactic surgery system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
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