FDA 510(k) Premarket Notification K113443: 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)

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BLOCK IMAGING SAS Registration: 3023003446 View Registration

Arrow Rapac Ltd. Registration: 3023217364 View Registration

SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 3023245 View Registration

3D ONS, INC. Registration: 3023266032 View Registration

Philips DS North America LLC Registration: 3023385454 View Registration

iRay Imaging Technology (Haining) Limited Registration: 3023546785 View Registration

ASSEMBLECIRCLE CORP. Registration: 3023702877 View Registration

AKUNAH Registration: 3024040179 View Registration

SINGULAR HEALTH PTY LTD Registration: 3024078470 View Registration

Straumann Manufacturing, Inc. Registration: 3024185724 View Registration

SOFTSMILE, INC. Registration: 3024438491 View Registration

AIRS Medical Inc. Registration: 3024820186 View Registration

Megagen Implant Co., Ltd. (Seoul Branch) Registration: 3025029560 View Registration

ACUMED LLC Registration: 3025141 View Registration

AI4MedImaging Medical Solutions S.A. Registration: 3025308066 View Registration

QUIBIM S.L. Registration: 3025343020 View Registration

DEEPLOOK MEDICAL, INC Registration: 3025394753 View Registration

QPIX SOLUTIONS, INC. Registration: 3025442726 View Registration

NEUROPHET, INC. Registration: 3025602618 View Registration

STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration

SMAART MEDICAL SYSTEMS, INC. Registration: 3025620599 View Registration

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AUGMENT INTELLIGENT MEDICAL SYSTEM (CHINA) CO., LTD. Registration: 3026309987 View Registration

IMAGE INSTRUMENTS GMBH Registration: 3026391019 View Registration

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ICAD INC. Registration: 3026970882 View Registration

Advantis Medical Imaging Single Member P.C. Registration: 3027158439 View Registration

Insight Surgery Houston Registration: 3027329005 View Registration

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 3027338963 View Registration

EZRA AI, INC. Registration: 3027347389 View Registration

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NANO-X IMAGING LTD Registration: 3027605321 View Registration

AVATAR MEDICAL Registration: 3027645731 View Registration

IMEKA SOLUTIONS INC. Registration: 3027977501 View Registration

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CARDIO FLOW DESIGN INC. Registration: 3029906636 View Registration

VUNO INC. Registration: 3029915548 View Registration

DRGEM Corporation (Gimcheon Factory) Registration: 3029916061 View Registration

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ONEPACS, LLC Registration: 3030228575 View Registration

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GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration

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MYCARDIUM AI LTD Registration: 3030446846 View Registration

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Ricoh 3D for Healthcare, LLC Registration: 3030977776 View Registration

CLARITAS HEALTHTECH LIMITED Registration: 3030979155 View Registration

IONIC HEALTH TECHNOLOGIES SA Registration: 3030982377 View Registration

CARPL.AI INC. Registration: 3031024978 View Registration

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GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Registration: 3032008018 View Registration

Merge Canada Registration: 3032014234 View Registration

FUJIFILM SONOSITE,INC. Registration: 3032367 View Registration

SYNTHESIS HEALTH INTELLIGENCE INC. Registration: 3032579549 View Registration

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BRAINSPEC, INC Registration: 3035371452 View Registration

PEEK HEALTH, S.A. Registration: 3035455070 View Registration

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FOVIA, INC. Registration: 3036471119 View Registration

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STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration

TAEYOUNG SOFT Registration: 3036758981 View Registration

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QFR SOLUTIONS BV Registration: 3038136528 View Registration

JLK, INC. Registration: 3038177848 View Registration

DEEPTEK MEDICAL IMAGING PVT. LTD Registration: 3038187462 View Registration

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MICROSTRUCTURE IMAGING, INC Registration: 3038191646 View Registration

ULTRAGREEN DATA SYSTEMS INC. Registration: 3040602603 View Registration

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3042175844 View Registration

LAON MEDI INC. Registration: 3042204491 View Registration

SEE-MODE TECHNOLOGIES PTY LTD Registration: 3042248552 View Registration

APQ HEALTH INC Registration: 3042369547 View Registration

Ricoh 3D for Healthcare Registration: 3042480122 View Registration

DRIVING FORCE VMA, LLC Registration: 3042625805 View Registration

TELTONIKA EMS - Moletai Technology Center Registration: 3042957826 View Registration

maihub Corp. Registration: 3043532712 View Registration

GOOD METHODS GLOBAL INC. Registration: 3043840131 View Registration

ADVAHEALTH SOLUTIONS Registration: 3044519982 View Registration

ONTACT HEALTH CO., LTD. Registration: 3044776706 View Registration

STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration

GE Healthcare Austria GmbH & Co OG Registration: 8020021 View Registration

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CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration

SION BIOTEXT MEDICAL LTD Registration: 8030128 View Registration

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Registration: 8030233 View Registration

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SAMSUNG MEDISON CO., LTD. Registration: 8041160 View Registration

ESAOTE S.P.A. Registration: 8043485 View Registration

TOMTEC Imaging Systems GMBH Registration: 8043836 View Registration

BRAINLAB SE Registration: 8043933 View Registration

GE VINGMED ULTRASOUND A/S Registration: 9610482 View Registration

KARL STORZ SE & CO. KG Registration: 9610617 View Registration

KLS Martin SE & Co. KG Registration: 9610905 View Registration

GE MEDICAL SYSTEMS SCS Registration: 9611343 View Registration

MEDICAL MEASUREMENT SYSTEMS B.V. Registration: 9611896 View Registration

NOBEL BIOCARE AB Registration: 9611992 View Registration

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BARCO N.V. Registration: 9613188 View Registration

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 9613299 View Registration

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GE HANGWEI MEDICAL SYSTEMS CO., LTD. Registration: 9613445 View Registration

Corin Limited Registration: 9614209 View Registration

MEDIS MEDICAL IMAGING SYSTEMS, B.V. Registration: 9614587 View Registration

CANON INC. Registration: 9614698 View Registration

SIRONA DENTAL SYSTEMS GMBH Registration: 9614977 View Registration

VEPRO AG Registration: 9614981 View Registration

CARL ZEISS MEDITEC AG (OBERKOCHEN) Registration: 9615010 View Registration

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INTELERAD MEDICAL SYSTEMS INCORPORATED Registration: 9615916 View Registration

SECTRA AB Registration: 9615992 View Registration

Visage Imaging GmbH Registration: 9616251 View Registration

AGFA HEALTHCARE N.V. Registration: 9616389 View Registration

Change Healthcare Israel Ltd. Registration: 9616760 View Registration

Wipro GE Healthcare Private Ltd. Registration: 9617277 View Registration

BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration

ZIMMER CAS Registration: 9617840 View Registration

PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. Registration: 9617978 View Registration

RAMSOFT, INC. Registration: 9680028 View Registration

VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration

AGFA HEALTHCARE INC. Registration: 9680497 View Registration

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Philips Medical Systems Technologies Ltd. Registration: 9681475 View Registration

PIE MEDICAL IMAGING B.V. Registration: 9710122 View Registration

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HERMES MEDICAL SOLUTIONS, AB Registration: 9710645 View Registration

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