LLZ · Class II · 21 CFR 892.2050

FDA Product Code LLZ: System, Image Processing, Radiological

FDA product code LLZ covers radiological image processing systems.

These are software and hardware platforms that acquire, process, display, and archive medical images from modalities such as CT, MRI, X-ray, and ultrasound. They are used across radiology departments, surgical suites, and telemedicine platforms.

LLZ devices are Class II medical devices, regulated under 21 CFR 892.2050 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Totoku Electric Co., Ltd. and Barco N.V..

2294

Total

2294

Cleared

106d

Avg days

1983

Since

Declining activity - 111 submissions in the last 2 years vs 153 in the prior period

Review times increasing: avg 150d recently vs 104d historically

FDA 510(k) Cleared System, Image Processing, Radiological Devices (Product Code LLZ)

2294 devices

1–24 of 2294

1 2 3 4

Cleared Oct 29, 2026

Vitrea Advanced Visualization, Version 7.16

K263648

Canon Medical Informatics, Inc.

Higia., Inc. d/b/a Eden

Perception Vision Medical Technology Co., Ltd.

Radiology · 166d

Cleared Sep 29, 2026

Syngo Carbon Space (VA4)

K263048

Siemens Healthineers AG

Radiology · 29d

Cleared Sep 23, 2026

Syneris PACS v.1.0.1.0

Elucid Bioimaging, Inc.

Taiwan Main Orthopaedic Biotechnology Co., Ltd.

Radiopharmaceutical Imaging & Dosimetry, LLC

ADVAHEALTH SOLUTIONS, LLC

Neurocareai, Inc. (Dba Savelife.Ai)

TheraSphere 360™ Y-90 Management Platform

K262462

Boston Scientific Corporation

Perfusion Measurement Platform v1

K253421

Quantified Imaging Limited

Radiology · 264d

1 2 3 4

About Product Code LLZ - Regulatory Context

510(k) Submission Activity

2294 total 510(k) submissions under product code LLZ since 1983, with 2294 receiving FDA clearance (average review time: 106 days).

Submission volume has declined in recent years - 111 submissions in the last 24 months compared to 153 in the prior period.

FDA 510(k) Review Time - LLZ Product Code

Recent submissions under LLZ have taken an average of 150 days to reach a decision - up from 104 days historically. Manufacturers should account for longer review timelines in current project planning.

LLZ devices are reviewed by the Radiology panel. Browse all Radiology devices →

FDA Product Code LLZ: System, Image Processing, Radiological

FDA 510(k) Cleared System, Image Processing, Radiological Devices (Product Code LLZ)

About Product Code LLZ - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - LLZ Product Code

Related FDA 510(k) Regulatory Insights