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 |
|---|---|---|---|
| Jan 7, 2025 | K241808 | ApolloHipX (THR.SS.0001) Corin U.S.A. Limited | LLZ |
| Jan 6, 2025 | K242123 | Brainomix 360 e-CTA Brainomix Limited, GB | LLZ |
| Jan 3, 2025 | K241350 | Clarify DL Ge Medical Systems Israel, Functional Imaging, IL | LLZ |
| Dec 20, 2024 | K242599 | aprevo® Digital Planning Carlsmed, Inc. | LLZ |
| Dec 20, 2024 | K242362 | Lightning Viewer Nexsys Electronics Inc. Dba Medweb | LLZ |
| Dec 6, 2024 | K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert Cercare Medical A/S, DK | LLZ |
| Dec 6, 2024 | K240926 | PeekMed web Peek Health, S.A., PT | LLZ |
| Dec 5, 2024 | K243447 | Rapid Surgical Plan (RSP-SW-001) Navbit Pty, Ltd., AU | LLZ |
| Nov 26, 2024 | K242810 | RadUnity (Version 1.0.0) Radunity Corp. | LLZ |
| Nov 21, 2024 | K241495 | Jazz Classic Jazz Imaging | LLZ |
| Nov 18, 2024 | K242329 | CT Collaboration Live Philips Healthcare (Suzhou) Co., Ltd., CN | LLZ |
| Nov 15, 2024 | K242062 | 1CMR Pro Mycardium AI Limited, GB | LLZ |
| Nov 12, 2024 | K241981 | Change Healthcare Stratus Imaging PACS Change Healthcare Canada Company, CA | LLZ |
| Nov 4, 2024 | K242709 | JLK-PWI JLK, Inc., KR | LLZ |
| Oct 31, 2024 | K241223 | eRAD PACS Erad, Inc. | LLZ |
| Oct 24, 2024 | K242512 | ROCC Console Philips Medical Systems Nederland B.V., NL | LLZ |
| Oct 23, 2024 | K243012 | MIM Symphony HDR Fusion Mim Software, Inc. | LLZ |
| Oct 22, 2024 | K243209 | nordicMEDiVA Nordicneurolab AS, NO | LLZ |
| Oct 16, 2024 | K242556 | JLK-CTP JLK, Inc., KR | LLZ |
| Oct 15, 2024 | K240385 | VINT Mediimg Corporation, KR | LLZ |
| Oct 11, 2024 | K241569 | syngo Application Software Siemens Medical Solutions USA, Inc. | LLZ |
| Sep 23, 2024 | K240243 | EConsole2 DRTECH Corporation, KR | LLZ |
| Sep 12, 2024 | K241524 | Elucid PlaqueIQ Elucid Bioimaging, Inc. | LLZ |
| Sep 5, 2024 | K233998 | TRAQinform IQ Aiq Global, Inc. | LLZ |
| Aug 23, 2024 | K241302 | SonoSync Samsung Medison Co., Ltd., KR | LLZ |
| Aug 21, 2024 | K240290 | AiMIFY (1.x) Subtle Medical, Inc. | LLZ |
| Aug 13, 2024 | K241094 | Bullsai Turing Medical Technologies, Inc. | LLZ |
| Aug 8, 2024 | K240724 | SynthVISION 1.0.0 Synthesis Health Intelligence, Inc., CA | LLZ |
| Aug 5, 2024 | K233761 | Orthopaedic Surgery Planning Software (AIJOINT) Longwood Valley Medical , Ltd., CN | LLZ |
| Jul 23, 2024 | K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) Ewoosoft Co., Ltd., KR | LLZ |
| Jul 18, 2024 | K241879 | vRad Viewer Virtual Radiologic Corporation | LLZ |
| Jul 17, 2024 | K241121 | MICSI-RMT Microstructure Imaging, Inc. | LLZ |
| Jul 17, 2024 | K240705 | Vitrea Software Package, VSTP-002A V2.0 Canon Medical Systems Corporation, JP | LLZ |
| Jul 2, 2024 | K241300 | ViewPoint 6 Ge Healthcare GmbH, DE | LLZ |
| Jul 1, 2024 | K233908 | cNeuro cDAT Combinostics OY, FI | LLZ |
| Jun 28, 2024 | K241608 | nordicMEDiVA Nordicneurolab AS, NO | LLZ |
| Jun 17, 2024 | K233331 | MediOMx Pmx, Inc. | LLZ |
| May 31, 2024 | K240281 | Bone Suppression Software Konica Minolta, Inc., JP | LLZ |
| May 31, 2024 | K223427 | Mimics Enlight CMF Materialise NV, BE | LLZ |
| May 23, 2024 | K240294 | Syngo Carbon Enterprise Access (VA40A) Siemens Healthcare GmbH, DE | LLZ |
| May 21, 2024 | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout Brainlab AG, DE | LLZ |
| May 20, 2024 | K233620 | MIM - Centiloid Scaling Mim Software, Inc. | LLZ |
| May 13, 2024 | K232862 | MIM Monte Carlo Dosimetry Mim Software, Inc. | LLZ |
| May 9, 2024 | K232976 | VUZE System Vuze Medical , Ltd., IL | LLZ |
| May 6, 2024 | K232514 | MIM Dose Analysis Mim Software, Inc. | LLZ |
| Apr 29, 2024 | K233699 | SubtleREFORMAT (1.x) Subtle Medical, Inc. | LLZ |
| Apr 24, 2024 | K240839 | OpenRad Cloud Openrad Services Uk, Ltd., GB | LLZ |
| Apr 24, 2024 | K240822 | Image Management V15 Philips Medical Systems Technologies, IL | LLZ |
| Apr 22, 2024 | K233582 | Rapid Ischemaview, Inc. | LLZ |
| Apr 10, 2024 | K232641 | Neorad Pacs (Neorad Pacs) Everrtech Software Pvt, Ltd., IN | LLZ |
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