iQ-solutions
by Sydney Neuroimaging Analysis Centre Pty Ltd
510(k) K231929
iQ-solutions is a medical device (FDA Class II; FDA product code QIH, Automated Radiological Image Processing Software) made by Sydney Neuroimaging Analysis Centre Pty Ltd, cleared under FDA 510(k) K231929 on 18 Dec 2023, 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 | FDA 510(k)SESE | NumberK231929 | Date18 Dec 2023 | StatusActive |
Official records
- FDA 510(k) database K231929
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- FDA applicant
- Sydney Neuroimaging Analysis Centre Pty, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K231929
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| iQ-solutions™ 1.12.6 | 1.12.6 | 00860011623908 | — | On the market |
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