{"product_name":"Perimeter S-Series OCT","company_name":"Perimeter Medical Imaging AI","product_url":"https://perimetermed.com/products/s-series-oct","company_url":"https://perimetermed.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0217","summary":"Perimeter S-Series OCT is an intraoperative imaging system that provides high-resolution, real-time visualization of excised tissue margins, aiding surgeons in achieving clear margins during cancer surgeries.","description":"Perimeter S-Series OCT utilizes Optical Coherence Tomography (OCT) to produce ultra-high-resolution, cross-sectional images of tissue microstructures at 10 times the resolution of ultrasound and X-ray, and 100 times that of MRI. This technology enables surgeons to assess surgical margins at the cellular level in real-time, facilitating immediate clinical decisions and potentially reducing the need for re-excision surgeries. The device is non-invasive, does not contact the patient, and preserves tissue for histopathological analysis. It has 510(k) clearance under a general indication and has not been evaluated by the FDA for specific uses such as breast tissue, breast cancer, other types of cancer, margin evaluation, and reducing re-excision rates. The safety and effectiveness of these uses have not been established.","categories":["imaging Software","surgical Navigation","medical Device","Clinical Imaging","Surgical Navigation","Intraoperative Imaging","Medical Devices"],"market_segment":["Enterprise","SMB"],"target_users":["Surgeons","Oncologists","Pathologists"],"specialties":["Surgical Oncology","Breast Surgery","Head And Neck Surgery","Thyroid Surgery"],"regions_available":["United States","Canada","Europe","Asia","Australia"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Chinese","Japanese","Korean","Arabic","Russian","Hindi","Bengali","Punjabi","Javanese","Turkish","Vietnamese","Telugu","Marathi","Tamil","Urdu"],"pricing_model":"Enterprise Quote","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Canada","United Kingdom","Germany","France","Italy","Spain","Australia","Japan","South Korea"],"company_founding":"2015","deployment_model":["on_prem"],"os_platforms":["Windows","macOS","Linux"],"features":["High-resolution imaging","Real-time margin visualization","Cross-sectional 3D imaging","Cellular-level tissue visualization","Image review manipulation software","Intuitive interface for image annotation","Optimized for surgical margin assessment","Non-invasive operation","No radiation exposure","Tissue preservation for pathology"],"optional_modules":["ImgAssist AI 2.0"],"integrations":["Perimeter B-Series OCT with ImgAssist AI 2.0"],"data_standards":["DICOM"],"api_available":"no","system_requirements":"Windows 10 or later, macOS 10.15 or later, Linux kernel 4.4 or later","compliance":["FDA 510(k) clearance","HIPAA","ISO 13485","ISO 14971","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16","IEC 60601-1-17","IEC 60601-1-18","IEC 60601-1-19","IEC 60601-1-20","IEC 60601-1-21","IEC 60601-1-22","IEC 60601-1-23","IEC 60601-1-24"],"certifications":["FDA 510(k) clearance","CE Mark","Health Canada Medical Device License","TGA ARTG Registration","ANVISA Registration","KFDA Approval","PMDA Approval","MHLW Approval","NMPA Approval","MHRA Registration","Swissmedic Approval","MedSafe Approval"],"security_features":["Data encryption","Role-based access control (RBAC)","Audit logs","Secure data storage","User authentication","Data integrity checks","Access control lists (ACLs)","Session management","Data masking","Secure data transmission"],"privacy_features":["Data anonymization","Data minimization","User consent management","Data retention policies","Data access controls","Data sharing policies","Data breach notification procedures","Data subject rights management","Data processing agreements","Third-party risk assessments"],"data_residency":"US-only","customers":["FirstWatch","Perimeter Medical Imaging AI","Perimeter S-Series OCT"],"user_reviews":["The entire platform including the automation tools make it simple to manage vendor risk.","How the tool can be tailored to suit needs and the support provided by the vendor."],"ratings":["4.8 out of 5 stars on G2 with 41 reviews"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2017","integration_partners":["Perimeter Medical Imaging AI","Perimeter S-Series OCT"],"id":"SW0217","slug":"perimeter-s-series-oct","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/perimeter-s-series-oct.json"}}