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) → LLZ — System, Image Processing, Radiological

# LLZ · System, Image Processing, Radiological

_Radiology · 21 CFR 892.2050 · Class 2_

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

## Overview

- **Product Code:** LLZ
- **Device Name:** System, Image Processing, Radiological
- **Regulation:** [21 CFR 892.2050](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.2050)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **3rd-party reviewable:** yes

## 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 2287)

Showing 20 most recent of 2287 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K262060](/device/K262060.md) | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | Sep 4, 2026 | SESE |
| [K261500](/device/K261500.md) | KBA3D (v2.4.0) | S.M.A.I.O | Aug 17, 2026 | SESE |
| [K262449](/device/K262449.md) | AdvaView | ADVAHEALTH SOLUTIONS, LLC | Aug 14, 2026 | SESE |
| [K261916](/device/K261916.md) | NeuroQuant PET | Cortechs Labs, Inc. | Aug 12, 2026 | SESE |
| [K260936](/device/K260936.md) | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | Jul 31, 2026 | SESE |
| [K260588](/device/K260588.md) | Cleerly LABS | Cleerly, Inc. | Jul 29, 2026 | SESE |
| [K262462](/device/K262462.md) | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | Jul 24, 2026 | SESE |
| [K262143](/device/K262143.md) | ImageGrid StreamVue | Candelis, Inc. | Jul 23, 2026 | SESE |
| [K260500](/device/K260500.md) | ResolutionMD | ResolutionMD, Inc. | Jul 21, 2026 | SESE |
| [K262120](/device/K262120.md) | Avara Viewer | Avara Software | Jul 10, 2026 | SESE |
| [K253899](/device/K253899.md) | 3D-Anywhere | Provect.AI | Jul 9, 2026 | SESE |
| [K261465](/device/K261465.md) | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | Jul 6, 2026 | SESE |
| [K260576](/device/K260576.md) | MeVis AVM Contour | MeVis Medical Solutions AG | Jun 30, 2026 | SESE |
| [K260231](/device/K260231.md) | MiPACS V5 (1.0.0) | Apryse Software Corp | Jun 25, 2026 | SESE |
| [K253421](/device/K253421.md) | Perfusion Measurement Platform v1 | Quantified Imaging Limited | Jun 22, 2026 | SESE |
| [K261352](/device/K261352.md) | 2D Hip Planning Software | One Ortho | Jun 8, 2026 | SESE |
| [K260116](/device/K260116.md) | CustoMED Viewer | CustoMED , Ltd. | Jun 3, 2026 | SESE |
| [K254265](/device/K254265.md) | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | May 27, 2026 | SESE |
| [K253831](/device/K253831.md) | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | May 18, 2026 | SESE |
| [K254013](/device/K254013.md) | SubtleHD-PET (1.x) | Subtle Medical, Inc. | May 14, 2026 | SESE |

## Top Applicants

- Siemens Medical Solutions USA, Inc. — 74 clearances
- Totoku Electric Co., Ltd. — 40 clearances
- Barco N.V. — 37 clearances
- Eizo Nanao Corporation — 34 clearances
- Vital Images, Inc. — 34 clearances

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

**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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