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 |
|---|---|---|---|
| K260206 | uplanner b.v. - presurgeo | SkeletonPlanner | July 15, 2026 |
| K260973 | beijing infervision healthcare medical technology co | InferOperate Suite | July 7, 2026 |
| K253628 | agada medical | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | June 29, 2026 |
| K253969 | adas3d medical s.l | ADAS 3D | June 29, 2026 |
| K253786 | siemens medical solutions usa | syngo.CT Coronary Cockpit | June 25, 2026 |
| K260316 | cercare medical | CMN Capillary Function with Oncology Virtual Expert | June 22, 2026 |
| K261713 | fujifilm healthcare americas corporation | Synapse PACS (7.6.0) | June 18, 2026 |
| K253172 | crescom co | MediAI-OA | June 15, 2026 |
| K253690 | siemens healthineers | LungMaps | June 15, 2026 |
| K260300 | anumana | WatchMate Software | 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 |
| K260234 | smart alfa teknoloji san. ve tic. a.s | MSK Go | May 21, 2026 |
| K254131 | deephealth | BAC | May 21, 2026 |
| K261289 | medicrea international s.a.s. (medtronic) | UNiD Spine Analyzer (SW3002) | May 15, 2026 |
| K254120 | subtle medical | SubtleHD-CT (1.x) | May 15, 2026 |