Perimeter S-Series OCT
JSON twin: https://www.healthaidb.com/software/perimeter-s-series-oct.json
Company Name
Perimeter Medical Imaging AI
Product URL
https://perimetermed.com/products/s-series-oct
Company URL
https://perimetermed.com
Categories
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.
Api Available
no
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
Company Founding
2015
Company Offices
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
Customers
- FirstWatch
- Perimeter Medical Imaging AI
- Perimeter S-Series OCT
Data Residency
US-only
Data Standards
Deployment Model
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
Id
SW0217
Integration Partners
- Perimeter Medical Imaging AI
- Perimeter S-Series OCT
Integrations
- Perimeter B-Series OCT with ImgAssist AI 2.0
Languages Supported
- English
- Spanish
- French
- German
- Italian
- Portuguese
- Chinese
- Japanese
- Korean
- Arabic
- Russian
- Hindi
- Bengali
- Punjabi
- Javanese
- Turkish
- Vietnamese
- Telugu
- Marathi
- Tamil
- Urdu
Last Updated
2025-10-11
License
Commercial
Market Segment
Optional Modules
Os Platforms
Pricing Details
Contact vendor for pricing information.
Pricing Model
Enterprise Quote
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
Product Code
SW0217
Product Name
Perimeter S-Series OCT
Ratings
- 4.8 out of 5 stars on G2 with 41 reviews
Regions Available
Related Urls
Release Year
2017
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
Specialties
Support Channels
- email
- phone
- chat
- ticketing
- community
- 24x7
System Requirements
Windows 10 or later, macOS 10.15 or later, Linux kernel 4.4 or later
Target Users
- Surgeons
- Oncologists
- Pathologists
Training Options
- documentation
- webinars
- live_online
- onsite
- certification
Type
product
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.
Version
1.0
Alternatives
See related products
Canonical JSON
{
"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"
}
}