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PathVisionXL

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183142

by Faxitron Bioptics, LLC

Identifiers

510(k) Number
K183142 FDA 510(k)
FDA Product Code
MWP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1680 FDA 510(k)
Regulation Number
892.1680 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PathVisionXL is a Cabinet, X-Ray System designed for preclinical imaging. It generates high-resolution X-ray images to visualize small animal models, bone structures, and implanted devices, supporting research in radiology and biomedical studies.

This system is intended for use in controlled laboratory or research settings. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accurate imaging. The PathVisionXL is classified as a Class II device under FDA regulation 892.1680 and holds a Traditional 510(k) clearance (K183142) with a Radiology advisory committee review. Multiple registration numbers (e.g., 3010478247) correspond to its authorized variants.

Frequently asked questions

What types of research studies is the PathVisionXL primarily used for in preclinical imaging settings?

The PathVisionXL is designed for preclinical imaging in controlled laboratory or research environments, particularly for visualizing small animal models, bone structures, and implanted devices. Its high-resolution X-ray capabilities make it suitable for radiology and biomedical studies where detailed imaging of these subjects is critical.

Is the PathVisionXL intended for single-use or reusable applications, and what maintenance is required?

The PathVisionXL is supplied as a reusable medical device, meaning it is not designed for single-use. To ensure accurate imaging, it requires proper calibration and regular maintenance, as outlined in the manufacturer’s guidelines.

What regulatory pathway was followed for the FDA clearance of the PathVisionXL, and what classification does it hold?

The PathVisionXL received a Traditional 510(k) clearance (K183142) through the FDA’s review process, specifically under the Radiology advisory committee (RA). It is classified as a Class II device under FDA regulation 892.1680, indicating it has been determined to be substantially equivalent to a predicate device.

Are there multiple variants of the PathVisionXL, and how can I identify the registration numbers associated with them?

Yes, the PathVisionXL has multiple authorized variants, each with its own registration number. These include 3010478247, 3017889703, 3005496266, 3006051164, 3026962577, and 3027847687. These numbers correspond to different configurations or models of the device, as listed in the FDA’s OpenFDA database.

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: K183142 FDA 510(k) - PathVisionXL | Faxitron Bioptics, LLC, X-rays preclinical imaging system - PathVision - Faxitron Bioptics ..., PDF Faxitron Bioptics, LLC - Food and Drug Administration, Faxitron Bioptics PathVisionXL - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Faxitron Bioptics, LLC

Sources (1)

  • FDA 510(k) K183142 24 fields · synced Sep 19, 2026