iQ-solutions™ 1.12.6
by Sydney Neuroimaging Analysis Centre Pty Ltd
iQ-solutions 1.12.6 is a medical device (FDA Class II) made by Sydney Neuroimaging Analysis Centre Pty Ltd, cleared under FDA 510(k) K231929 on 18 Dec 2023 and listed in FDA GUDID since 22 May 2024 (UDI-DI 00860011623908), 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 | Number00860011623908 | Date22 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231929 | Date18 Dec 2023 | StatusActive |
Official records
- AccessGUDID record 00860011623908
- FDA 510(k) database K231929
Across registries
- FDA 510(k) K231929 decided 18 Dec 2023 Active
- FDA GUDID UDI-DI 00860011623908 listed 22 May 2024 Listed
Timeline
- Cleared FDA 510(k) K231929
- Listed FDA GUDID 00860011623908
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iQ-solutions™
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.12.6
- Primary DI / UDI-DI
- 00860011623908
- 510(k) Number
- FDA product code
- QIH, LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radiology DICOM image processing application software.
- 3mensio Workstation 10.7 by Pie Medical Imaging B.V.
- CAAS MR Solutions 5.3 by Pie Medical Imaging B.V.
- Advanced Visualization Workspace 881120 by Philips Medical Systems Nederland B.V.
- icobrain ctp 1 by icometrix NV
- RConsole1 1.0 by Drtech Corp.
- Quantra 2.2 R2LIC-2103-V2.2 by Hologic
- Corridor4DM C4DM10 by Invia
- CINA-iPE 1.0 by AVICENNA.AI
- EConsole1 by Drtech Corp.
- EDDA TECHNOLOGY IQQA-BodyImaging by EDDA Technology, Inc.