Product code LLZClass 2
System, Image Processing, Radiological 510(k) Clearances
Product code LLZ is the FDA classification for System, Image Processing, Radiological, a Class 2 device regulated under 21 CFR 892.2050, reviewed by the FDA Radiology panel. FDA has cleared 2,271 510(k) submissions under this product code.
Every device cleared under product code LLZ shares the same intended use and device type, so they are candidate predicate devices for a new 510(k) of this type. Open any device below to see its full clearance record and its candidate predicates.
- Cleared devices
- 2,271
- Device class
- Class 2
- Regulation
- 892.2050
- Latest clearance
- 2026-06-03
Cleared devices under product code LLZ
Showing the 50 most recent of 2,271 cleared devices. Clearances from 2025-07-14 to 2026-06-03.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 |
| K260479 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 2026-02-06 |
| K251577 | LAIA XR | Augmented Reality Software S.L. | 2026-02-06 |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | 2026-01-08 |
| K253639 | View | GE Healthcare | 2026-01-08 |
| K253008 | maiLink | Maihub Corp. | 2026-01-05 |
| K251883 | MIM LesionID Pro | Mim Software, Inc. | 2025-12-11 |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | 2025-11-21 |
| K253495 | syngo.MR Applications (VB80) | Siemens Healthineers AG | 2025-11-20 |
| K251410 | VXvue | Vieworks Co., Ltd. | 2025-11-04 |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2025-11-03 |
| K252547 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | 2025-10-28 |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical | 2025-10-22 |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | 2025-10-16 |
| K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025-10-15 |
| K251363 | ProKnow DS | Elekta Solutions AB | 2025-10-08 |
| K250039 | HPACS | Healthhub | 2025-10-03 |
| K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | 2025-10-02 |
| K250045 | uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-24 |
| K250040 | uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-12 |
| K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. | 2025-09-11 |
| K252608 | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | 2025-09-09 |
| K251168 | Image Suite | Carestream Health, Inc. | 2025-09-04 |
| K250290 | SurgiTwin | Twinsight | 2025-08-29 |
| K252526 | Rapid DeltaFuse | Ischemaview, Inc. | 2025-08-26 |
| K243680 | Neurovascular Insight V1.0 | Olea Medical S.A.S. | 2025-08-25 |
| K232456 | RW-1 | Mediott, Inc. | 2025-08-11 |
| K250664 | Navigo Workstation 2.3 (FPRMC00039) | UC-CARE , Ltd. | 2025-08-07 |
| K251038 | Digital Radiographic Imaging Acquisition Software - DR (RiasDR) | Shen Zhen Cambridge-Hit Co., Ltd. | 2025-08-06 |
| K244016 | iPETcertum (v1.0) | Claritas Healthtech Pte, Ltd. | 2025-08-05 |
| K250716 | IMAGE ONE | Infomed Software, S.L. | 2025-07-23 |
| K243681 | Neuro Insight V1.0 | Olea Medical S.A.S. | 2025-07-23 |
| K250686 | GyriCalc (Version 1.0.0) | Neurospectrum Insights Corp. | 2025-07-22 |
| K250181 | AV Viewer | Philips Medical Systems Nederland B.V. | 2025-07-15 |
| K250120 | GECHO | Narnar, LLC | 2025-07-14 |
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