OTIS 2.1 Optical Coherence Tomography
Overview
The OTIS 2.1 Optical Coherence Tomography System, also known as THiA Optical Coherence Tomography System, is an advanced imaging tool developed by Perimeter Medical Imaging AI. It is designed for the evaluation of excised human tissue microstructure, providing two-dimensional, cross-sectional, real-time depth visualization. The system includes image review manipulation software that enables users to identify and annotate regions of interest within the tissue samples.
Utilizing Optical Coherence Tomography (OCT) technology, OTIS 2.1 operates similarly to ultrasound but employs non-ionizing, low-power optical radiation to generate high-resolution, sub-surface images of tissue. This technology is foundational to Perimeter Medical Imaging AI’s broader mission to transform cancer surgery, particularly in breast conservation, by providing surgeons with real-time insights to achieve clean margins and potentially reduce the need for re-excisions. While OTIS 2.1 itself is primarily an imaging device, it represents an earlier iteration of the company’s technology, which has since evolved into products like the S-Series OCT and the investigational B-Series OCT with ImgAssist AI, which incorporates artificial intelligence for enhanced detection capabilities.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Optical Coherence Tomography (OCT) imaging
- Two-dimensional, cross-sectional visualization
- Real-time depth visualization of excised tissue
- Image review manipulation software
- Identification and annotation of regions of interest
- High-resolution imaging of tissue microstructure
- Non-ionizing, low-power optical radiation
- Automated scanning of specimen surface
- Cart-based system for portability in the OR
Use Cases
- Evaluation of excised human tissue microstructure during surgery
- Intraoperative margin visualization in cancer surgery
- Assisting surgeons in achieving clean margins
- Potentially reducing re-excision rates in breast conservation surgery
- Providing real-time insights for surgical decision-making
- Complementing traditional pathology by offering immediate visualization
Details
| Category | Oncology AI, Pathology AI, Surgical AI |
| Pricing | Contact for pricing — Not publicly available; typically involves direct sales and custom quotes. |
| Deployment | On-premise (cart-mounted system for operating room use) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated The OTIS 2.1 Optical Coherence Tomography System (K203578) received 510(k) clearance from the U.S. FDA on February 25, 2021. It is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization with image review manipulation software for identifying and annotating regions of interest. |
| Integrations | |
| EHR | Not specified |
| Specialties | General Surgery, Pathology |
What the Web Says
The OTIS 2.1 Optical Coherence Tomography system is an imaging tool designed for evaluating excised human tissue microstructure, providing real-time, two-dimensional, cross-sectional depth visualization. It offers high-resolution imaging, significantly more detailed than ultrasound or MRI, and aims to assist surgeons in assessing surgical margins to potentially reduce re-excision rates in cancer surgeries, particularly breast cancer. The system has received FDA 510(k) clearance for general use in evaluating excised human tissue.
Overall: PositiveStrengths
- Provides real-time, high-resolution, sub-surface imaging of excised tissue.
- Offers significantly higher resolution compared to ultrasound (10x) and MRI (100x).
- Aids surgeons in intraoperative margin assessment, potentially reducing re-excision surgeries.
- Non-destructive imaging, preserving tissue for subsequent histology.
- Automates OCT scanning of the specimen surface, standardizing image collection.
- Allows for concurrent image review and acquisition.
Limitations
- The S-Series OCT (which includes OTIS 2.1) has a general FDA 510(k) clearance and has not been specifically evaluated by the FDA for use in breast tissue, breast cancer, other cancer types, margin evaluation, or reducing re-excision rates.
- Without AI assistance, interpreting thousands of images generated during a scan can be time-consuming for surgeons.
- Reimbursement pathways for new medical devices can take time (e.g., 6 months to 2-3 years).
- The system requires a single-use consumable for each procedure.
Based on reviews from: Perimeter Medical Imaging AI, Inc. Cindy Domecus Regulatory Consultant Domecus Consulting Services, LLC 1171 Barroihet Avenu - accessdata.fda.gov, Perimeter, OTIS u2013 Optical Coherence Tomography and the Future of AI in Surgical Breast Cancer Treatment - Chimera Research Group, DEVICE: S-Series OCT (00754016215049) - AccessGUDID - NIH, Wide-field optical coherence tomography for microstructural analysis of key tissue types: a proof-of-concept evaluation - PMC, Perimeter Medical Imaging AI on FDA Clearance, AI-Assisted Surgery and 2026 Catalysts, Clinical Literature - Perimeter Medical Imaging, 510(k) Premarket Notification - FDA, Real-world Insights - Perimeter Medical Imaging, Expanding Application of Optical Coherence Tomography Beyond the Clinic: A Narrative Review - MDPI, Perimeter pioneering high resolution wide-field tissue imaging for tumor specimens, Groundbreaking OCT imaging for visualizing surgical margins in the OR
Last updated: 2026-07-20
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