ADAS 3D v2.9
ADAS 3D v2.9 is a surgical simulation system (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by ADAS3D Medical S.L., cleared under FDA 510(k) K210850 on 5 Apr 2021 and listed in FDA GUDID since 9 Mar 2022 (UDI-DI 08437021722055), 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 | Number08437021722055 | Date9 Mar 2022 | StatusListed |
| United States | FDA 510(k) | NumberK210850 | Date5 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 08437021722055
- FDA 510(k) database K210850
Across registries
- FDA 510(k) K210850 decided 5 Apr 2021 Active
- FDA GUDID UDI-DI 08437021722055 listed 9 Mar 2022 Listed
Timeline
- Cleared FDA 510(k) K210850
- Listed FDA GUDID 08437021722055
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Adas 3D
- Generic name
- Surgical simulation system
- Model / reference
- v2.9
- Primary DI / UDI-DI
- 08437021722055
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Surgical simulation system
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- FDXConsole DR-ID300CL by FUJIFILM CORPORATION
- Color LCD Display, Model Radiforce R22 by Eizo Nanao Corporation
- ORS Visual by Object Research Systems, Inc.
- Kostec Medical Grade Ldc Monitors by Kostec Co., Ltd.
- Isg 3DMV Workstation by I.S.G. Technologies, Inc.
- Suitestensa by Ebit Srl
- R4 Acert Ultrasound Reporting System by R4, LLC
- Deep Gray by CORTECHS LABS INC
- EchoSoft by Echometrix, LLC
- GE ECHOPAC by GE Healthcare