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cCeLL - In vivo with Drop-In Robo - DR200

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251852

by VPIX Medical, Inc.

Identifiers

510(k) Number
K251852 FDA 510(k)
FDA Product Code
OWN FDA 510(k)
Models / Variants
CN100-2W2C488775 FDA 510(k)
CN100-1W1C775 FDA 510(k)
DR200 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ccell - In Vivo With Drop-In Robo is a confocal optical imaging system intended for in vivo use with a drop‑in robotic fiber‑optic probe. The system provides high‑resolution imaging of internal tissue microstructure, allowing visualization of cells, vessels and tissue architecture in gastrointestinal and urological applications.

The device is supplied as a complete imaging system with the specified probe models (CN100-2W2C488775, CN100-1W1C775, DR200) and is classified as a Class II medical device (product code OWN) under FDA 510(k) clearance (decision date 2026‑02‑13, regulation 876.1500). It is intended for use in clinical settings by qualified personnel, with the regulatory status reflecting substantial equivalence to a predicate device.

Frequently asked questions

What is the cCeLL - In Vivo with Drop-In Robo system used for?

The cCeLL - In Vivo with Drop-In Robo is a confocal optical imaging system designed for in vivo use with a drop-in robotic fiber-optic probe. It provides high-resolution imaging of internal tissue microstructure, allowing visualization of cells, vessels and tissue architecture in gastrointestinal and urological applications.

What probe models are compatible with the cCeLL - In Vivo system?

The cCeLL - In Vivo system is supplied with three specific probe models: CN100-2W2C488775, CN100-1W1C775, and DR200. These probes are designed to work with the imaging system to provide high-resolution visualization of tissue microstructure in clinical settings.

Is the cCeLL - In Vivo system reusable or single-use?

The device is supplied as a complete imaging system with the specified probe models. The description does not specify whether the system or individual components are designed for single-use or multiple uses, so this information would need to be obtained directly from the manufacturer.

What is the regulatory status of the cCeLL - In Vivo system?

The cCeLL - In Vivo with Drop-In Robo system has FDA 510(k) clearance with a decision date of 2026-02-13, classified as a Class II medical device under product code OWN. It is intended for use in clinical settings by qualified personnel, with regulatory status reflecting substantial equivalence to a predicate device.

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: cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200), cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775 ..., cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200), cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
VPIX Medical, Inc.

Sources (1)

  • FDA 510(k) K251852 24 fields · synced Oct 6, 2026