System, Image Processing, Radiological
Regulation 892.2050
48510(k)s in 12 months (2,295 all time)
25recalls in 12 months (562 all time)
544recalls that name a 510(k)
Top companies in LLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens AG Medical Solutions | 95 | 89 |
| GE Healthcare | 23 | 84 |
| Merge Healthcare Incorporated | 6 | 61 |
| Carestream Health, Inc. | 9 | 53 |
| Vital Images, Inc. | 34 | 10 |
| Agfa Corp. | 6 | 34 |
| Totoku Electric Co., Ltd. | 40 | 0 |
| Barco N.V. | 37 | 0 |
| Eizo Nanao Corporation | 34 | 0 |
| Ewoosoft Co., Ltd. | 29 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 2025 | K252547 | TheraSphere 360 Y-90 Management Platform Boston Scientific Corporation | LLZ |
| Oct 22, 2025 | K251030 | Sirona Advanced Imaging Suite Sirona Medical | LLZ |
| Oct 16, 2025 | K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout Brainlab AG, DE | LLZ |
| Oct 15, 2025 | K252199 | AGFA HealthCare Enterprise Imaging Agfa Healthcare N.V., BE | LLZ |
| Oct 8, 2025 | K251363 | ProKnow DS Elekta Solutions AB, SE | LLZ |
| Oct 3, 2025 | K250039 | HPACS Healthhub, KR | LLZ |
| Oct 2, 2025 | K251215 | Philips IntelliSpace Cardiovascular Philips Medical Systems Nederland B.V., NL | LLZ |
| Sep 24, 2025 | K250045 | uWS-Angio Pro Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Sep 12, 2025 | K250040 | uWS-Angio Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Sep 11, 2025 | K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) Augment Intelligent Medical System (China) Co., Ltd., CN | LLZ |
| Sep 9, 2025 | K252608 | AI-Rad Companion Prostate MR Siemens Healthcare GmbH, DE | LLZ |
| Sep 4, 2025 | K251168 | Image Suite Carestream Health, Inc. | LLZ |
| Aug 29, 2025 | K250290 | SurgiTwin Twinsight, FR | LLZ |
| Aug 26, 2025 | K252526 | Rapid DeltaFuse Ischemaview, Inc. | LLZ |
| Aug 25, 2025 | K243680 | Neurovascular Insight V1.0 Olea Medical S.A.S., FR | LLZ |
| Aug 11, 2025 | K232456 | RW-1 Mediott, Inc., JP | LLZ |
| Aug 7, 2025 | K250664 | Navigo Workstation 2.3 (FPRMC00039) UC-CARE , Ltd., IL | LLZ |
| Aug 6, 2025 | K251038 | Digital Radiographic Imaging Acquisition Software - DR (RiasDR) Shen Zhen Cambridge-Hit Co., Ltd., CN | LLZ |
| Aug 5, 2025 | K244016 | iPETcertum (v1.0) Claritas Healthtech Pte, Ltd., SG | LLZ |
| Jul 23, 2025 | K250716 | IMAGE ONE Infomed Software, S.L., ES | LLZ |
| Jul 23, 2025 | K243681 | Neuro Insight V1.0 Olea Medical S.A.S., FR | LLZ |
| Jul 22, 2025 | K250686 | GyriCalc (Version 1.0.0) Neurospectrum Insights Corp. | LLZ |
| Jul 15, 2025 | K250181 | AV Viewer Philips Medical Systems Nederland B.V., NL | LLZ |
| Jul 14, 2025 | K250120 | GECHO Narnar, LLC | LLZ |
| Jul 7, 2025 | K251863 | CustomSurg OrthoPlanner Customsurg AG, CH | LLZ |
| Jun 17, 2025 | K243666 | uOmniscan Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Jun 16, 2025 | K244012 | Mosaic (V1.0.1) Navier Medical, AU | LLZ |
| Jun 5, 2025 | K250800 | UroNav 4 Philips DS North America, LLC | LLZ |
| Jun 5, 2025 | K243703 | TechLive DeepHealth, Inc. | LLZ |
| May 21, 2025 | K251109 | SMARTDent Ray Co., Ltd., KR | LLZ |
| May 12, 2025 | K243632 | uWS-Angio Basic Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| May 2, 2025 | K243069 | LUMYS (V1) Intradys, FR | LLZ |
| Apr 23, 2025 | K243697 | MySpine WebPlanner Medacta International S.A., CH | LLZ |
| Apr 21, 2025 | K243651 | VersaViewer GE Medical Systems SCS, FR | LLZ |
| Apr 16, 2025 | K242647 | MySegmenter (v2.0.0) Mysegmenter Technologies, Inc. | LLZ |
| Apr 14, 2025 | K250301 | Merge Universal Viewer (MUV) Merge Healthcare Incorporated | LLZ |
| Apr 8, 2025 | K242552 | Horos Mobile Icat Solutions, Ltd., GB | LLZ |
| Mar 20, 2025 | K243292 | brAIn Shoulder Positioning Avatar Medical, FR | LLZ |
| Mar 18, 2025 | K242161 | Radlink GPS Pro Imaging Radlink, Inc. | LLZ |
| Mar 17, 2025 | K241975 | SERV MEDICAL CDSS Serv Medical Pte., Ltd., SG | LLZ |
| Mar 14, 2025 | K241765 | PLANET Onco Dose (3.2) Dosisoft SA, FR | LLZ |
| Feb 26, 2025 | K241546 | aiCockpit AI Viewer Fovia, Inc. | LLZ |
| Feb 25, 2025 | K250348 | JLK-AILink JLK, Inc., KR | LLZ |
| Feb 21, 2025 | K242838 | QuickRad Aikenist Technologies Pvt, Ltd., IN | LLZ |
| Feb 20, 2025 | K242240 | CaRi-Plaque Caristo Diagnostics , Ltd., GB | LLZ |
| Feb 12, 2025 | K241425 | AspenView Aspen Imaging Healthcare, Inc. | LLZ |
| Feb 4, 2025 | K243333 | rTOP Roclub GmbH, DE | LLZ |
| Jan 31, 2025 | K241694 | ZeTTA PACS Tae Young Soft Co., Ltd., KR | LLZ |
| Jan 23, 2025 | K241819 | CephNinja Cyncronus, LLC | LLZ |
| Jan 14, 2025 | K242205 | SpectoMed (v1.0) Specto Medical, CH | LLZ |
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