Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- GCILaryngoscope, Endoscope2Product Code
- GCJLaparoscope, General & Plastic Surgery2Product Code
- MFJDevice, Endoscopic Suturing2Product Code
- EPYSpeculum, Ent1Product Code
- NAYSystem, Surgical, Computer Controlled Instrument2Product Code
- NEQDevice, Telemedicine, Robotic2Product Code
- PDTBurn Resuscitation Decision Support Software2Product Code
- FDPApparatus, Pneumoperitoneum, Automatic2Product Code
- GCGPeritoneoscope2Product Code
- GCHMediastinoscope, Diagnostic2Product Code
- OTJLaparoscopic Single Port Access Device2Product Code
- OWNConfocal Optical Imaging2Product Code
- K241275Histolog® Scanner (Hardware 2.4, Software 3.3)2Cleared 510(K)
- K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit2Cleared 510(K)
- K232857KARL STORZ ICG Imaging System2Cleared 510(K)
- K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM2Cleared 510(K)
- K231344ActivSight Intraoperative Imaging System2Cleared 510(K)
- K230407FloNavi Open Field Fluorescence Imaging System2Cleared 510(K)
- K230754L12 LED Light Source with AIM2Cleared 510(K)
- K213943SmartSurgN Visualization System2Cleared 510(K)
- K223020VS3-Iridium System (VS3-IR)2Cleared 510(K)
- K221611780 nm L11 LED Light Source with AIM2Cleared 510(K)
- K220477Cellvizio 100 series system with confocal Miniprobes2Cleared 510(K)
- K210265VS3 Iridium Sytem2Cleared 510(K)
- K212695KARL STORZ ICG Imaging System2Cleared 510(K)
- K212322Cellvizio I.V.E. system with Confocal Miniprobes2Cleared 510(K)
- K203550ActivSight Intraoperative Imaging System2Cleared 510(K)
- K202925KARL STORZ ICG Imaging System2Cleared 510(K)
- K202244SPY-PHI System with SPY-PHI Fluorescence Assessment Software2Cleared 510(K)
- K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head2Cleared 510(K)
- K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head2Cleared 510(K)
- K200737SPY Portable Handheld Imaging (SPY-PHI) System2Cleared 510(K)
- K193416Cellvizio I.V.E. with Confocal Miniprobes2Cleared 510(K)
- K191144Cellvizio 100 Series System with Confocal Miniprobes2Cleared 510(K)
- K191851VS3-IR2Cleared 510(K)
- K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable2Cleared 510(K)
- K192174SPY Portable Handheld Imaging (SPY-PHI) System2Cleared 510(K)
- K191046L10 LED Light Source with AIM, L11 LED Light Source with AIM2Cleared 510(K)
- K190729SPY Portable Handheld Imaging (SPY-PHI) System2Cleared 510(K)
- K183453VS3-IR2Cleared 510(K)
- K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes2Cleared 510(K)
- K173866Stryker AIM Light Source and SafeLight cable2Cleared 510(K)
- K172844Cellvizio 100 Series System with Confocal Miniprobes2Cleared 510(K)
- K171345Cellvizio 100 Series Systems with Confocal Miniprobes2Cleared 510(K)
- K171238KARL STORZ ICG Imaging System2Cleared 510(K)
- K162882KARL STORZ ICG Imaging System2Cleared 510(K)
- K162885SPY Phi Open Field Handheld Fluorescence Imaging System2Cleared 510(K)
- K152583KARL STORZ Endoscopic ICG Imaging System2Cleared 510(K)
- K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes2Cleared 510(K)
- K150831Cellvizio 100 Series System with Confocal Miniprobes2Cleared 510(K)
- K152204VS3-IR system2Cleared 510(K)
- K151593Cellvizio 100 Series System with Confocal Miniprobes2Cleared 510(K)
- K143474Artemis Hand Held Imaging System2Cleared 510(K)
- K150018VS3-IR-MMS System2Cleared 510(K)
- K142310Stryker Infrared Fluorescence (IRF) Imaging System2Cleared 510(K)
- K141358CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES2Cleared 510(K)
- K133466CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)2Cleared 510(K)
- K132475FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM2Cleared 510(K)
- K132389CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED2Cleared 510(K)
- K124031DA VINCI FLUORESCENCE IMAGING VISION SYSTEM2Cleared 510(K)
- K123676CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES2Cleared 510(K)
- K122042CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES2Cleared 510(K)
- K120208CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES2Cleared 510(K)
- K110480PDE PHOTODYNAMIC EYE2Cleared 510(K)
- K111047CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES2Cleared 510(K)
- QGYMobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera2Product Code
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)2Product Code
- POYPost Breast Biopsy Hemostatic Breast Compression Device2Product Code
- FXESpeculum, Non-Illuminated1Product Code
- FXFSpeculum, Illuminated1Product Code
- FXGSpecula Accessories1Product Code
- JYKHolder, Ear Speculum1Product Code
- KAGHolder, Speculum, Ent1Product Code
- QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured2Product Code
- QZBSoftware Controlled Endoscope And Instrument Holder2Product Code
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K200542
- 510(k) Type
- Traditional
- Applicant
- Olympus Medical Systems Corp.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/17/2020
- Days to Decision
- 136 days
- Submission Type
- Summary