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
- QGYMobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera2Product Code
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)2Product Code
- K252851deepLive (OSP12 + DMS)2Cleared 510(K)
- K251198HyperVue™ Software2Cleared 510(K)
- K250684OPUSWAVE Dual Sensor Imaging System2Cleared 510(K)
- K242924OPXION Optical Skin Viewer (OPXSV1-01F)2Cleared 510(K)
- K242098Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)2Cleared 510(K)
- K243016Starlight Imaging Catheter2Cleared 510(K)
- K242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))2Cleared 510(K)
- K240610deepLive2Cleared 510(K)
- K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.62Cleared 510(K)
- K230691HyperVue™ Imaging System2Cleared 510(K)
- K221257SpectraWAVE Imaging System2Cleared 510(K)
- K210458OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System2Cleared 510(K)
- K203578OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System2Cleared 510(K)
- K201552ApolloVue S100 Image System2Cleared 510(K)
- K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter2Cleared 510(K)
- K191117NvisionVLE Low-profile Optical Probe2Cleared 510(K)
- K183320Ilumien Optis, Optis Integrated, Optis Mobile2Cleared 510(K)
- K190404OTIS Optical Coherence Tomography SYstem2Cleared 510(K)
- K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System2Cleared 510(K)
- K182261NvisionVLE Imaging System, NvisionVLE Optical Probe2Cleared 510(K)
- K171560OTIS Optical Coherence Tomography System2Cleared 510(K)
- K162466LuminScan (TM) Imaging System2Cleared 510(K)
- K153283VivoSight Dx Topical OCT System2Cleared 510(K)
- K160878OPTIS Metallic Stent Optimization E.4 SW2Cleared 510(K)
- K160240Perimeter Otis™ 1.0 Optical Coherence Tomography System2Cleared 510(K)
- K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System2Cleared 510(K)
- K152120OPTIS Mobile System2Cleared 510(K)
- K151286OPTIS Integrated System Mobile Workstation2Cleared 510(K)
- K150878ILUMIEN OPTIS2Cleared 510(K)
- K150237ILUMIEN, Drageonfly OPTIS Imaging Catheter2Cleared 510(K)
- K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory2Cleared 510(K)
- K133209FORESEE (4C) IMAGING SYSTEM2Cleared 510(K)
- K132800SKINTELL2Cleared 510(K)
- K120800NVISION VLE IMAGING SYSTEM2Cleared 510(K)
- K123369ILUMIEN OPTIS2Cleared 510(K)
- K121195NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER2Cleared 510(K)
- K112770NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER2Cleared 510(K)
- K111201C7 XR IMAGING SYSTEM2Cleared 510(K)
- K102599TOMOPHASE OCTIS2Cleared 510(K)
- K093857C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES2Cleared 510(K)
- K093520VIVOSIGHT TOPICAL OCT SYSTEM2Cleared 510(K)
- K042894IMALUX NIRIS IMAGING SYSTEM2Cleared 510(K)
- K033783IMALUX OCT IMAGING SYSTEM2Cleared 510(K)
- 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
- SFEEndoscopic Video Imaging System / Software Component For Real Time Video Augmentation2Product 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
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K203578
- 510(k) Type
- Special
- Applicant
- Perimeter Medical Imaging AI, Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/25/2021
- Days to Decision
- 80 days
- Submission Type
- Summary