QIH — Automated Radiological Image Processing Software Class II
FDA product code QIH covers "Automated Radiological Image Processing Software", a Class II medical device regulated under 21 CFR 892.2050. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261623 | Ge Medical Systems Ultrasound And Primary Care Diagnostics | EchoPAC Software Only / EchoPAC Plug-in (v211) | Sep 16, 2026 |
| K261677 | Aramis Global Ai Consultancies | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Sep 15, 2026 |
| K261795 | Omniscient Neurotechnology Pty | Quicktome Software Suite | Sep 10, 2026 |
| K260879 | Invia | 4DM | Sep 10, 2026 |
| K251417 | Argus Cognitive | ReVISION 2 | Sep 9, 2026 |
| K260525 | Mri2Ct | NextMR Spine | Sep 4, 2026 |
| K260811 | Heartvue.Ai | Heartvue.Proton | Aug 26, 2026 |
| K261595 | Ceevra | Ceevra Reveal 4 | Aug 25, 2026 |
| K260584 | Mriguidance | BoneMRI | Aug 21, 2026 |
| K262127 | Dentsply Sirona | DS Core CBCT Anatomy | Aug 21, 2026 |
| K261641 | Ai Planning Logic | Lower Limb AI (LLAI) | Aug 18, 2026 |
| K253794 | Lucida Medical | Prostate Core | Aug 10, 2026 |
| K252571 | Mediaire | mdprostate | Aug 7, 2026 |
| K253902 | 3Diemme | RealGUIDE | Aug 4, 2026 |
| K253835 | Hermes Medical Solutions | Affinity | Jul 31, 2026 |
| K260980 | Curemetrix | cmAngio® V2.0 | Jul 30, 2026 |
| K261210 | Cleerly | Cleerly Plaque | Jul 29, 2026 |
| K260192 | Ropca Aps | DIANA | Jul 24, 2026 |
| K261349 | Airs Medical | SwiftMR | Jul 24, 2026 |
| K254096 | Velmeni | VELMENI for DENTISTS (V4D) 3D | Jul 23, 2026 |