iSR'obot Mona Lisa 1.0
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203659 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iSR'obot Mona Lisa 1.0 is an ultrasonic pulsed echo imaging system (Regulation Name: 21 CFR 892.1560, Product Code: IYO), designed for real-time imaging in radiology procedures. It integrates robotic precision with ultrasound technology to facilitate targeted diagnostic and therapeutic interventions, particularly in minimally invasive procedures.
This device is supplied as a Class II medical instrument, intended for single-use or reusable applications depending on manufacturer guidelines. It is regulated under FDA 510(k) clearance (K203659) and the European Medical Device Directive (MDD), with MRI safety considerations noted in its specifications. Storage and handling follow standard sterile or non-sterile protocols as defined by the manufacturer, ensuring compliance with radiology workflows.
Frequently asked questions
What types of medical procedures is the iSR'obot Mona Lisa 1.0 primarily used for, and how does it differ from traditional ultrasound imaging?
The iSR'obot Mona Lisa 1.0 is designed for real-time imaging in radiology procedures, combining robotic precision with ultrasound technology to assist in targeted diagnostic and therapeutic interventions. Unlike traditional ultrasound imaging, which relies on manual operator control, this device integrates robotic guidance to enhance accuracy and consistency during minimally invasive procedures. Its primary application lies in scenarios where precise imaging and intervention are critical, such as in certain interventional radiology or surgical settings.
Is the iSR'obot Mona Lisa 1.0 intended for single-use or reusable applications, and what are the manufacturer’s guidelines for handling?
The iSR'obot Mona Lisa 1.0 is classified as a Class II medical instrument and can be used either as a single-use device or as a reusable instrument, depending on the manufacturer’s guidelines. Proper storage and handling protocols—whether sterile or non-sterile—must align with Biobot Surgical’s instructions to ensure compliance with radiology workflows and maintain device integrity. Always refer to the manufacturer’s documentation for specific cleaning, sterilization, or reuse procedures.
What regulatory pathways does the iSR'obot Mona Lisa 1.0 follow, and how does this impact its use in different markets?
The iSR'obot Mona Lisa 1.0 has obtained FDA 510(k) clearance (K203659) under the Traditional pathway, with a decision described as Substantially Equivalent to a predicate device, and it complies with the European Medical Device Directive (MDD). This means it is legally marketable in the U.S. and EU markets under these respective regulatory frameworks. However, buyers should confirm local compliance requirements, as regulations may evolve or vary by jurisdiction.
Does the iSR'obot Mona Lisa 1.0 have any special considerations for use in MRI environments, and how should this affect its placement or handling?
The device includes MRI safety considerations in its specifications, which means it is designed with materials and features that account for potential electromagnetic interference or compatibility issues in MRI environments. When using or storing the iSR'obot Mona Lisa 1.0 near MRI equipment, follow the manufacturer’s guidelines to ensure safe operation and avoid compromising imaging quality or patient safety. Always verify compatibility with specific MRI systems in use.
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: Pte iSR'obot Mona Lisa 1.0 - allmed.wiki, iSR'obot Mona Lisa 1.0 (K203659) — FDA 510 (k) | Innolitics, Biobot Surgical — Unmatched Precision. Unequivocal Excellence.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K203659 | Class II | Active |
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Manufacturer
- Manufacturer
- Biobot Surgical Pte. Ltd.
- FDA Applicant
- Biobot Surgical Pte., Ltd.
Sources (2)
- FDA 510(k) K203659 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026