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 |
|---|---|---|---|
| K252261 | beijing infervision healthcare medical technology co | InferCare RECIST | March 13, 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 |
| K253057 | siemens healthcare | AI-Rad Companion Brain MR | January 22, 2026 |
| K253735 | philips medical systems nederland | AV Vascular | January 22, 2026 |
| K252634 | softlink international private limited | Imagine® Enterprise Suite | January 16, 2026 |
| K253532 | spectrum dynamics medical | TruSPECT Processing Station | December 30, 2025 |
| K252856 | peek health | PeekMed web | December 22, 2025 |
| K252029 | heartlung corporation | AI-CVD | December 19, 2025 |
| K252670 | topia medtech limited | Alzevita | December 19, 2025 |
| K252235 | ultrasight | PVAD IQ Software | December 18, 2025 |
| K250914 | crescom co | MediAI-BA | December 18, 2025 |
| K252922 | neosoma | Neosoma Brain Mets | December 17, 2025 |
| K251763 | intuitive surgical | IRISeg | December 16, 2025 |