iotaSOFT Insertion System IM-05
iotaSOFT Insertion System IM-05 is a robotic surgical system application software (FDA Class II; FDA product code QQH, Powered Insertion System For A Cochlear Implant Electrode Array) made by Iotamotion, Inc., granted FDA De Novo DEN190055 on 1 Oct 2021 and listed in FDA GUDID since 20 Sep 2024 (UDI-DI 00850002960068), active as of 23 Oct 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850002960068 | Date20 Sep 2024 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN190055 | Date1 Oct 2021 | StatusActive |
Official records
- AccessGUDID record 00850002960068
- FDA De Novo database DEN190055
Across registries
- FDA De Novo DEN190055 decided 1 Oct 2021 Active
- FDA GUDID UDI-DI 00850002960068 listed 20 Sep 2024 Listed
Timeline
- Granted FDA De Novo DEN190055
- Listed FDA GUDID 00850002960068
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- iotaSOFT Insertion System
- Generic name
- Robotic surgical system application software
- Model / reference
- IM-05
- Primary DI / UDI-DI
- 00850002960068
- De Novo Number
- FDA product code
- QQH
- GMDN term
- Robotic surgical system application software
- Device class
- Class II
- Regulation number
- 874.4450
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe