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 |
|---|---|---|---|
| K261713 | fujifilm healthcare americas corporation | Synapse PACS (7.6.0) | June 18, 2026 |
| K260300 | anumana | WatchMate Software | June 15, 2026 |
| K253690 | siemens healthineers | LungMaps | June 15, 2026 |
| K253172 | crescom co | MediAI-OA | June 15, 2026 |
| K260406 | brainomix limited | Brainomix 360 Hyperdensity | June 12, 2026 |
| K260322 | mighty oak medical | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | June 11, 2026 |
| K260497 | keya medical technology co | DEEPVESSEL Plaque | June 4, 2026 |
| K260077 | orthogrid systems | OrthoGrid Hip AI® 4.0 | May 29, 2026 |
| K261405 | imeka solutions | ANDI 2.2 | May 28, 2026 |
| K260324 | canon medical informatics | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | May 22, 2026 |
| K254131 | deephealth | BAC | May 21, 2026 |
| K260234 | smart alfa teknoloji san. ve tic. a.s | MSK Go | May 21, 2026 |
| K261289 | medicrea international s.a.s. (medtronic) | UNiD Spine Analyzer (SW3002) | May 15, 2026 |
| K252563 | neurophet | Neurophet SCALE PET | May 15, 2026 |
| K261273 | neurophet | Neurophet AQUA | May 15, 2026 |
| K254120 | subtle medical | SubtleHD-CT (1.x) | May 15, 2026 |
| K260032 | beaubrain healthcare | Morph | May 13, 2026 |
| K254189 | fujifilm corporation | Synapse 3D Base Tools (V7.2) | April 30, 2026 |
| K254184 | siemens medical solutions usa | syngo Application Software | April 29, 2026 |
| K260785 | dentsply sirona | DS Core CBCT Anatomy | April 23, 2026 |