TECHFIT Diagnostic Models

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• DEEPHEALTH Registration: 3018733944 View Registration
• ULTRASPECT USA, LLC Registration: 3018788582 View Registration
• UNIK ORTHOPEDICS, INC Registration: 3019006180 View Registration
• Philips Ultrasound LLC Registration: 3019216 View Registration
• Arthrex Australia Pty Ltd. Registration: 3019269298 View Registration
• OVERJET Registration: 3019544554 View Registration
• QMENTA Registration: 3019674997 View Registration
• THERAPANACEA Registration: 3019834893 View Registration
• CERCARE MEDICAL A/S Registration: 3019844085 View Registration
• INSIGHT MEDICAL SYSTEMS, INC Registration: 3019878658 View Registration
• Alphatec Spine, Inc. Registration: 3019878714 View Registration
• SPINTECH, INC. Registration: 3020162557 View Registration
• Arthrex New Zealand Limited Registration: 3020704423 View Registration
• LAZARUS 3D, INC. Registration: 3020858025 View Registration
• EverFortune.AI Co., Ltd. Registration: 3021032044 View Registration
• REALIZE MEDICAL INC. Registration: 3021163566 View Registration
• MEDIT CORP. Registration: 3021233709 View Registration
• Dental Imaging Technologies Corporation Registration: 3021551875 View Registration
• WHEELHOUSE MEDICAL Registration: 3021559833 View Registration
• ASTUTE IMAGING Inc Registration: 3021625328 View Registration
• MedCAD Registration: 3021635140 View Registration
• HEARTFLOW, INC. Registration: 3021637148 View Registration
• NICo-Lab B.V. Registration: 3021915828 View Registration
• Intelerad USA Registration: 3022435840 View Registration
• Ricoh 3D for Healthcare, LLC Registration: 3022973841 View Registration
• 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
• 20MED PTE LTD Registration: 3026047529 View Registration
• AUGMENT INTELLIGENT MEDICAL SYSTEM (CHINA) CO., LTD. Registration: 3026309987 View Registration
• IMAGE INSTRUMENTS GMBH Registration: 3026391019 View Registration
• Covidien Registration: 3026612481 View Registration
• VOXIMETRY Registration: 3026768398 View Registration
• 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
• Xironetic R&D Center Registration: 3027408258 View Registration
• NANO-X IMAGING LTD Registration: 3027605321 View Registration
• AVATAR MEDICAL Registration: 3027645731 View Registration
• IMEKA SOLUTIONS INC. Registration: 3027977501 View Registration
• CLEARADVANCE, LLC Registration: 3029877582 View Registration
• CARDIO FLOW DESIGN INC. Registration: 3029906636 View Registration
• VUNO INC. Registration: 3029915548 View Registration
• DRGEM Corporation (Gimcheon Factory) Registration: 3029916061 View Registration
• DENTI.AI TECHNOLOGY INC. Registration: 3029956998 View Registration
• REBRAIN Registration: 3030088963 View Registration
• TECHSOMED Registration: 3030089065 View Registration
• MOTILENT LTD Registration: 3030179922 View Registration
• ATOMICA TECHNOLOGY, INC Registration: 3030228551 View Registration
• ONEPACS, LLC Registration: 3030228575 View Registration
• ENHATCH, INC Registration: 3030409224 View Registration
• GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration
• ICAT SOLUTIONS LTD Registration: 3030446518 View Registration
• MYCARDIUM AI LTD Registration: 3030446846 View Registration
• ORCA DENTAL AI Registration: 3030655434 View Registration
• 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
• Biotronics 3D Limited Registration: 3031755019 View Registration
• 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
• GE Vingmed Ultrasound AS Registration: 3032807464 View Registration
• GE Vingmed Ultrasound AS Registration: 3033508292 View Registration
• STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
• VUZE MEDICAL LTD. Registration: 3033524690 View Registration
• Philips India Limited - Diagnostic X-ray Business Unit Registration: 3033525986 View Registration
• Philips India Limited - Image Guided Therapy Systems Business Unit Registration: 3033525987 View Registration
• Philips Global Business Services LLP - Ultrasound Business Unit Registration: 3033527241 View Registration
• Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units Registration: 3033527273 View Registration
• Philips India Limited - Image Guided Therapy Systems Business Unit Registration: 3033527282 View Registration
• Philips India Limited - Ultrasound Business Unit Registration: 3033527283 View Registration
• Philips India Limited - Diagnostic X-ray Business Unit Registration: 3033527770 View Registration
• SOTA CLOUD CORPORATION Registration: 3034604691 View Registration
• BRAINSPEC, INC Registration: 3035371452 View Registration
• PEEK HEALTH, S.A. Registration: 3035455070 View Registration
• AIRAMED GMBH Registration: 3035707772 View Registration
• FOVIA, INC. Registration: 3036471119 View Registration
• Q BIO Registration: 3036495186 View Registration
• AUGMEDIT Registration: 3036725840 View Registration
• STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration
• TAEYOUNG SOFT Registration: 3036758981 View Registration
• Insight Surgery Nebraska Registration: 3038011206 View Registration
• SPECTO MEDICAL AG Registration: 3038136320 View Registration
• QFR SOLUTIONS BV Registration: 3038136528 View Registration
• JLK, INC. Registration: 3038177848 View Registration
• DEEPTEK MEDICAL IMAGING PVT. LTD Registration: 3038187462 View Registration
• ROCLUB GMBH Registration: 3038189169 View Registration
• 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
• Trophy Registration: 8020825 View Registration
• 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
• Planmeca Oy Registration: 8030876 View Registration
• 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
• NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) Registration: 9612330 View Registration
• BARCO N.V. Registration: 9613188 View Registration
• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Registration: 9613299 View Registration
• STORZ MEDICAL AG Registration: 9613347 View Registration
• 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
• SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. Registration: 9615439 View Registration
• 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
• ORTHOFIX SRL Registration: 9680825 View Registration
• Philips Medical Systems Technologies Ltd. Registration: 9681475 View Registration
• PIE MEDICAL IMAGING B.V. Registration: 9710122 View Registration
• GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration
• HERMES MEDICAL SOLUTIONS, AB Registration: 9710645 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.