FDA.reportPublic FDA data

510(k) K234113

Device
MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
Applicant
Medimaging Integrated Solution, Inc (Miis)
510(k) number
K234113
Product code
EOQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-01
Date received
2023-12-27
Regulation
874.4680
Classification name
Bronchoscope (Flexible Or Rigid)
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sandy Chou
Address
Industry E. Rd. Iv, Hsinchu Science Park, Hsinchu, R.O.C. 3f., #24-2 Hsinchu TW 30077 30077

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EOQ#

510(k), Device, Applicant table
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K252045Ion Endoluminal System (IF1000)Intuitive Surgical, Inc.2025-09-23
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K250232Vathin® Video Bronchoscope SystemHunan Vathin Medical Instrument Co., Ltd.2025-07-25
K250862EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)Olympus Medical Systems Corp.2025-06-23
K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation2025-06-13
K250118Disposable Balloon Catheter B5-2COlympus Medical Systems Corporation2025-06-04
K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)Olympus Medical Systems Corporation2025-05-30