QIH — Automated Radiological Image Processing Software Class II
Classification Details
- Product Code
- QIH
- Device Class
- Class II
- Regulation Number
- 892.2050
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253502 | ge medical systems | Critical Care Suite with Enteric Tube Positioning AI Algorithm | April 14, 2026 |
| K252708 | relu | Relu Cloud | April 10, 2026 |
| K253930 | overjet | Overjet Iris Intelligent Imaging System | April 10, 2026 |
| K253689 | siemens healthcare | syngo Dynamics (VA41F) | April 10, 2026 |
| K254015 | smart soft healthcare ad | CoLumbo C-Spine | April 1, 2026 |
| K254207 | vitaa medical solutions | AiORTA - Plan v2.0 | March 30, 2026 |
| K253775 | airs medical | SwiftMR | March 26, 2026 |
| K253614 | philips medical systems nederland | EchoNavigator R5.0 | March 17, 2026 |
| K253944 | voronoi health analytics incorporated | Data Analysis Facilitation Suite (DAFS) | March 16, 2026 |
| K252261 | beijing infervision healthcare medical technology co | InferCare RECIST | March 13, 2026 |
| K253551 | depuy ireland uc | VELYS Hip Navigation | March 6, 2026 |
| K252538 | orca dental ai | CEPHX3D | March 5, 2026 |
| K253593 | clarius mobile health | Clarius Ejection Fraction AI | March 2, 2026 |
| K253535 | ligence uab | Ligence Heart | February 27, 2026 |
| K260217 | exo imaging | AI Platform 2.2 (AIP002) | February 24, 2026 |
| K252084 | ai4medimaging medical solutions | AI4CMR v2.0 | February 11, 2026 |
| K254016 | siemens medical solutions usa | MI View&GO | February 10, 2026 |
| K252496 | neurophet | Neurophet AQUA AD Plus | January 29, 2026 |
| K252091 | medicalvr | Surgical Reality Viewer | January 29, 2026 |
| K253735 | philips medical systems nederland | AV Vascular | January 22, 2026 |