Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.2050](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2050) → QIH — Automated Radiological Image Processing Software

# QIH · Automated Radiological Image Processing Software

_Radiology · 21 CFR 892.2050 · Class 2_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/QIH

## Overview

- **Product Code:** QIH
- **Device Name:** Automated Radiological Image Processing Software
- **Regulation:** [21 CFR 892.2050](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2050)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

## Classification Rationale

Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

## Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

## Recent Cleared Devices (20 of 329)

Showing 20 most recent of 329 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261795](/device/K261795.md) | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | Sep 10, 2026 | SESE |
| [K260879](/device/K260879.md) | 4DM | INVIA, LLC | Sep 10, 2026 | SESE |
| [K251417](/device/K251417.md) | ReVISION 2 | Argus Cognitive, Inc. | Sep 9, 2026 | SESE |
| [K260525](/device/K260525.md) | NextMR Spine | MRI2CT, Inc. | Sep 4, 2026 | SESE |
| [K260811](/device/K260811.md) | Heartvue.Proton | Heartvue.ai, Inc. | Aug 26, 2026 | SESE |
| [K261595](/device/K261595.md) | Ceevra Reveal 4 | Ceevra, Inc. | Aug 25, 2026 | SESE |
| [K262127](/device/K262127.md) | DS Core CBCT Anatomy | Dentsply Sirona | Aug 21, 2026 | SESE |
| [K260584](/device/K260584.md) | BoneMRI | Mriguidance B.V. | Aug 21, 2026 | SESE |
| [K261641](/device/K261641.md) | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | Aug 18, 2026 | SESE |
| [K253794](/device/K253794.md) | Prostate Core | Lucida Medical, Ltd. | Aug 10, 2026 | SESE |
| [K252571](/device/K252571.md) | mdprostate | Mediaire GmbH | Aug 7, 2026 | SESE |
| [K253902](/device/K253902.md) | RealGUIDE | 3DIEMME SRL | Aug 4, 2026 | SESE |
| [K253835](/device/K253835.md) | Affinity | Hermes Medical Solutions AB | Jul 31, 2026 | SESE |
| [K260980](/device/K260980.md) | cmAngio® V2.0 | Curemetrix, Inc. | Jul 30, 2026 | SESE |
| [K261210](/device/K261210.md) | Cleerly Plaque | Cleerly, Inc. | Jul 29, 2026 | SESE |
| [K261349](/device/K261349.md) | SwiftMR | Airs Medical, Inc. | Jul 24, 2026 | SESE |
| [K260192](/device/K260192.md) | DIANA | ROPCA ApS | Jul 24, 2026 | SESE |
| [K254096](/device/K254096.md) | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | Jul 23, 2026 | SESE |
| [K261535](/device/K261535.md) | Hi-D Imaging 4TAVR | Hi-D Imaging AG | Jul 20, 2026 | SESE |
| [K260206](/device/K260206.md) | SkeletonPlanner | UPlanner B.V. - Presurgeo | Jul 15, 2026 | SESE |

## Top Applicants

- Siemens Medical Solutions USA, Inc. — 12 clearances
- Dia Imaging Analysis, Ltd. — 10 clearances
- Shanghai United Imaging Healthcare Co., Ltd. — 6 clearances
- Clarius Mobile Health Corp. — 5 clearances
- Ischemaview, Inc. — 5 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/QIH](https://fda-staging.innolitics.com/productcode/QIH)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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