Identifiers
- 510(k) Number
- K231986 FDA 510(k)
- FDA Product Code
- IZI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1600 FDA 510(k)
- Regulation Number
- 892.1600 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Modus IR is a Near-Infrared Fluorescence Imaging Module designed as an accessory for surgical exoscopes. It enables intraoperative visualization of vascular structures and blood flow using fluorescence imaging, enhancing surgical precision under white light limitations. The device leverages optical signal detection to highlight anatomical features not visible conventionally, supporting procedures in radiology and neurosurgery.
Supplied as a reusable accessory for integration with Synaptive’s surgical exoscope systems, the Modus IR operates in controlled clinical environments such as operating rooms. It is classified as a Class II medical device under FDA regulations (21 CFR 892.1600) and holds a 510(k) clearance (K231986) for substantial equivalence. No sterility or single-use specifications are noted; compatibility is limited to compatible exoscope platforms. MRI safety and storage conditions are not detailed in the regulatory submission.
Frequently asked questions
What types of surgical procedures can the Modus IR help visualize during surgery?
The Modus IR is designed to enhance intraoperative visualization of vascular structures and blood flow using near-infrared fluorescence imaging. This technology is particularly useful in radiology and neurosurgery procedures where conventional white light may limit visibility of key anatomical features. It aids in identifying and highlighting blood vessels or perfusion areas that are not easily seen under standard lighting.
Is the Modus IR a single-use or reusable device, and what are its storage requirements?
The Modus IR is supplied as a reusable accessory for integration with Synaptive Medical’s surgical exoscope systems. Since it is reusable, proper cleaning and maintenance protocols must be followed per manufacturer guidelines. The regulatory submission does not specify storage conditions, so users should consult Synaptive Medical’s instructions for proper handling and storage to ensure optimal performance and longevity.
Which surgical exoscope systems is the Modus IR compatible with?
The Modus IR is designed as an accessory specifically for Synaptive Medical’s surgical exoscope systems. Compatibility is limited to those platforms explicitly supported by Synaptive, so users should verify compatibility with their existing exoscope model before integration. The device is not intended for standalone use.
What regulatory pathway was followed for the Modus IR’s clearance, and what class does it belong to?
The Modus IR received FDA clearance through a 510(k) pathway, specifically under the traditional review process, with a clearance number of K231986. It is classified as a Class II medical device under the FDA’s regulations (21 CFR 892.1600), indicating it poses moderate risk and requires pre-market review to ensure safety and effectiveness.
Does the Modus IR require sterilization before use, and if not, how is it prepared for clinical use?
The regulatory submission for the Modus IR does not specify any sterility requirements or mention single-use constraints, indicating it is intended for reuse. Preparation for clinical use would involve following Synaptive Medical’s cleaning and maintenance protocols to ensure proper hygiene and functionality. Users should refer to the manufacturer’s instructions for detailed guidance on preparation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Modus IR User Manual (MAN-0742 R-C), Synaptive, Synaptive Modus Ir - allmed.wiki, Modus IR (K231986) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231986 | Class II | Active |
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Manufacturer
- Manufacturer
- Synaptive Medical Inc
- FDA Applicant
- Synaptive Medical, Inc.
Sources (1)
- FDA 510(k) K231986 24 fields · synced Sep 20, 2026