FDA 510(k) Premarket Notification K243647: Synapse PACS (7.5)

Submission Details & Decision

Normalized public record details for 510(k) notification K243647.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K243647

Applicant / Sponsor

FUJIFILM Healthcare Americas Corporation

Device Name

Synapse PACS (7.5)

Product Code

QIH

Decision Date

2025-06-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-11-26

Related Establishments / Registrations

MEDICREA INTERNATIONAL Registration: 1000432246 View Registration
CORTECHS LABS, INC. Registration: 1226773 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1423253 View Registration
ENCORE MEDICAL, L.P. Registration: 1644408 View Registration
MEDICAL METRICS, INC. Registration: 1651903 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1818910 View Registration
Esaote North America, Inc Registration: 1826555 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 1836549 View Registration
GE PARALLEL DESIGN, INC. Registration: 2032350 View Registration
GE MEDICAL SYSTEMS, LLC Registration: 2126677 View Registration
Philips Ultrasound LLC Registration: 2518586 View Registration
SOUND TECHNOLOGY INC. Registration: 2532090 View Registration
STRYKER ENDOSCOPY Registration: 2936485 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Philips Medical Systems Nederland B.V. Registration: 3000976525 View Registration
INTUITIVE SURGICAL, INC. Registration: 3001675293 View Registration
FUJIFILM CORPORATION Registration: 3001722928 View Registration
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Registration: 3002183074 View Registration
Siemens Healthineers Ltd. Registration: 3002619337 View Registration
Siemens Healthineers AG Registration: 3002808157 View Registration
PARALLEL DESIGN SAS Registration: 3003594449 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office Registration: 3003775006 View Registration
BENCHMARK ELECTRONICS (THAILAND) PUBLIC COMPANY LI Registration: 3003899230 View Registration
ROCHE MOLECULAR SYSTEMS, INC. Registration: 3004141078 View Registration
FUJIFILM Healthcare Americas Corporation Registration: 3004972322 View Registration
Siemens Healthineers AG Registration: 3004977335 View Registration
Brainlab Ltd. Registration: 3005225421 View Registration
PALODEX GROUP OY Registration: 3005383085 View Registration
Philips Ultrasound (Shanghai) Co., Ltd Registration: 3005403518 View Registration
Nobel Biocare c/o Medicim NV Registration: 3005739655 View Registration
FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama Registration: 3005930550 View Registration
EOS imaging Registration: 3006165260 View Registration
Spectrum Dynamics Medical Ltd. Registration: 3006209933 View Registration
Siemens Healthineers Ltd. Registration: 3006985147 View Registration
VENTRIPOINT DIAGNOSTICS LTD. Registration: 3007194257 View Registration
CIRCLE CARDIOVASCULAR IMAGING INC Registration: 3007301305 View Registration
GEXPRO, a Division of REXEL USA, Inc. Registration: 3007545404 View Registration
AOA PRODUCTS LLC Registration: 3007630531 View Registration
OLEA MEDICAL Registration: 3007675959 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
Spectrum Dynamics Medical Inc. Registration: 3008007310 View Registration
GE Healthcare (China) Co., Ltd. Registration: 3008284470 View Registration
EvERX PTY LTD Registration: 3008496839 View Registration
Nobel Biocare Services AG Registration: 3008693672 View Registration
STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
LBN MEDICAL A/S Registration: 3009196578 View Registration
Philips Healthcare (Suzhou) Co., Ltd. Registration: 3009529630 View Registration
Roche Diagnostics Santa Clara Registration: 3009731198 View Registration
SAMSUNG MEDISON CO., LTD. Registration: 3009758186 View Registration
BUTTERFLY NETWORK, INC. Registration: 3010102386 View Registration
Koios Medical, Inc. Registration: 3010119782 View Registration
ORTHOGRID SYSTEMS, INC Registration: 3010342382 View Registration
Probo Medical Ltd Registration: 3010398867 View Registration
Philips Medical Systems Technologies Ltd Registration: 3010656400 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
REDSTONE HEALTHCARE LLC Registration: 3010952312 View Registration
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. Registration: 3011015597 View Registration
Ewoosoft Co., Ltd Registration: 3011189058 View Registration
ISCHEMAVIEW, INC. Registration: 3011205675 View Registration
PILSON DIRECT TRADING LIMITED Registration: 3011763071 View Registration
United Imaging Healthcare North America, Inc Registration: 3011950073 View Registration
CLARIUS MOBILE HEALTH CORP. Registration: 3012747207 View Registration
ESAOTE S.P.A. Registration: 3012981490 View Registration
Proton B.V. Registration: 3012987001 View Registration
ARTERYS INC. Registration: 3013306229 View Registration
RADFORMATION, INC. Registration: 3013410552 View Registration
QUANTIB BV Registration: 3013497030 View Registration
KICO KNEE INNOVATION COMPANY Registration: 3013552417 View Registration
3D-SIDE Registration: 3013561205 View Registration
ECHONOUS, INC. Registration: 3013757696 View Registration
DANELIS MEDICAL LIMITED Registration: 3013844297 View Registration
CEEVRA, INC. Registration: 3014132130 View Registration
Terarecon, Inc. Registration: 3014146081 View Registration
Hyperfine, Inc Registration: 3014310698 View Registration
BODY VISION MEDICAL LTD Registration: 3014491269 View Registration
Viz.ai Israel Ltd Registration: 3014665798 View Registration
VIZ.AI, INC. Registration: 3014678441 View Registration
Siemens Healthcare s.r.o. Registration: 3014745562 View Registration
UIH TECHNOLOGIES, LLC Registration: 3014809646 View Registration
AIDOC MEDICAL LTD. Registration: 3014938447 View Registration
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AMCAD BIOMED CORPORATION Registration: 3015218501 View Registration
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Subtle Medical Inc Registration: 3015425142 View Registration
DURR DENTAL SE Registration: 3015509619 View Registration
Depuy Ireland UC Registration: 3015516266 View Registration
CLARIPI INC. Registration: 3015537315 View Registration
INTUITIVE SURGICAL, INC. Registration: 3015612252 View Registration
Philips Medical Systems Technologies Ltd. Registration: 3015763655 View Registration
SOFTWARE NEMOTEC, S.L. Registration: 3016446349 View Registration
ADAS3D MEDICAL S.L Registration: 3016461002 View Registration
MEDICAL IP Co., Ltd. Registration: 3016579137 View Registration
ULTROMICS, LTD. Registration: 3016585383 View Registration
Therapixel Inc. Registration: 3016759115 View Registration
THERAPIXEL Registration: 3016819165 View Registration
AXIAL MEDICAL PRINTING LIMITED Registration: 3016824824 View Registration
IB LAB GMBH Registration: 3016965352 View Registration
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD Registration: 3017058304 View Registration
CLEERLY, INC Registration: 3017167291 View Registration
CUREMETRIX, INC. Registration: 3017173128 View Registration
BRAINOMIX LIMITED Registration: 3017210169 View Registration
ARTRYA Registration: 3017233423 View Registration
PRENUVO Inc. Registration: 3017297314 View Registration
EKO.AI PTE. LTD. Registration: 3017425832 View Registration
4DMEDICAL LIMITED Registration: 3017426576 View Registration
Exo Imaging, Inc. Registration: 3017487805 View Registration
QURE.AI TECHNOLOGIES PRIVATE LIMITED Registration: 3017840913 View Registration
Philips Ultrasound LLC Registration: 3017894900 View Registration
Infervision Medical Technology Co., Ltd. Registration: 3017936680 View Registration
CARLSMED, INC. Registration: 3017936978 View Registration
WHITERABBIT AI INC Registration: 3017976149 View Registration
DISIOR OY Registration: 3018064242 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
INHEART Registration: 3018302800 View Registration
DEEPHEALTH Registration: 3018733944 View Registration
Philips Ultrasound LLC Registration: 3019216 View Registration
GENESIS SOFTWARE INNOVATIONS Registration: 3019541896 View Registration
OVERJET Registration: 3019544554 View Registration
INSIGHT MEDICAL SYSTEMS, INC Registration: 3019878658 View Registration
FEOPS NV Registration: 3020703662 View Registration
PIUR IMAGING GMBH Registration: 3020928588 View Registration
ANGIOWAVE IMAGING, INC. Registration: 3021027284 View Registration
EverFortune.AI Co., Ltd. Registration: 3021032044 View Registration
HEARTFLOW, INC. Registration: 3021637148 View Registration
PEARL INC. Registration: 3021887566 View Registration
GLEAMER Registration: 3021907554 View Registration
VideaHealth, Inc. Registration: 3022719380 View Registration
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Arrow Rapac Ltd. Registration: 3023217364 View Registration
SIEMENS MEDICAL SOLUTIONS USA, INC. Registration: 3023245 View Registration
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AIRS Medical Inc. Registration: 3024820186 View Registration
CYCLE CLARITY Registration: 3024972425 View Registration
DGNCT LLC Registration: 3025110425 View Registration
QUIBIM S.L. Registration: 3025343020 View Registration
KEYA MEDICAL TECHNOLOGY CO.,LTD. Registration: 3025430791 View Registration
NEUROPHET, INC. Registration: 3025602618 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
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AVATAR MEDICAL Registration: 3027645731 View Registration
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SONIO Registration: 3029937167 View Registration
REBRAIN Registration: 3030088963 View Registration
TECHSOMED Registration: 3030089065 View Registration
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SIMBIOSYS, INC. Registration: 3030598283 View Registration
ORCA DENTAL AI Registration: 3030655434 View Registration
EDGECARE INC. Registration: 3031569584 View Registration
RELU BV Registration: 3031915908 View Registration
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CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration
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NOBEL BIOCARE AB Registration: 9611992 View Registration
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