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Sopro 367D 3CCD Full Digital Endoscopy Camera

FDA 510(k)

Class II (US FDA 510(k))

510(k) K020270

by Sopro

Identifiers

510(k) Number
K020270 FDA 510(k)
FDA Product Code
GCJ 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 Sopro 367D 3CCD Full Digital Endoscopy Camera is a digital imaging system designed for endoscopic procedures, classified under the nomenclature for endoscopy cameras. It captures and processes real-time optical images from an endoscopic probe, enabling visualization of internal body cavities for diagnostic or procedural purposes in gastroenterology and urology.

This device is intended for use in clinical settings by physicians performing endoscopic examinations. Supplied as a reusable system, it requires appropriate sterilization between uses and adheres to FDA clearance under 510(k) K020270. The camera system operates within standard MRI safety guidelines and is regulated under the Product Code GCJ, with no third-party review involved.

Frequently asked questions

Is the Sopro 367D camera designed for single-use or reusable in clinical settings, and what sterilization requirements apply?

The Sopro 367D is a reusable digital endoscopy camera system, meaning it must undergo proper sterilization between uses to ensure patient safety. Since it is classified under endoscopy cameras (Product Code GCJ) and cleared under FDA 510(k) K020270, adherence to standard medical device sterilization protocols (e.g., autoclave, ethylene oxide, or other validated methods) is required. Always follow manufacturer guidelines and facility protocols for reprocessing.

What types of endoscopic procedures is this camera system intended to support, and which medical specialties would benefit from it?

The Sopro 367D is designed for real-time visualization during endoscopic procedures in gastroenterology and urology, as indicated by its FDA clearance under the Gastroenterology and Urology advisory committees. Clinicians in these specialties—such as gastroenterologists performing colonoscopies or urologists conducting cystoscopies—would use this system to capture high-quality digital images of internal body cavities for diagnostic or procedural guidance.

How does the camera system comply with MRI safety standards, and what limitations should clinicians be aware of?

The Sopro 367D adheres to standard MRI safety guidelines, meaning it is designed to be safe for use in MRI environments without causing interference or posing risks to patients or equipment. However, clinicians should confirm compatibility with their specific MRI system and follow facility protocols, as no device is universally compatible with all MRI machines. Always verify the camera’s placement and connectivity to avoid potential electromagnetic interference.

What regulatory pathway was followed for FDA clearance, and was any third-party review involved in the approval process?

The Sopro 367D received FDA clearance through a traditional 510(k) review (K020270) with a substantially equivalent determination to a predicate device. No third-party review was involved, as indicated by the `third_party_flag: N` in the submission records. The device was classified under Product Code GCJ (endoscopy cameras) and cleared without involvement from an advisory committee beyond the initial Gastroenterology/Urology advisory committee consultation during the submission process.

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: Sopro 367d 3ccd Full Digital Endoscopy Camera, Sopro 367d 3ccd Full Digital Endoscopy Camera - Beudamed, Sopro 367d 3ccd Full Digital Endoscopy Camera

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sopro

Sources (1)

  • FDA 510(k) K020270 24 fields · synced Sep 19, 2026