← Back to catalogue

Swift Ray 1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251678

by Swift Medical, Inc.

Identifiers

510(k) Number
K251678 FDA 510(k)
FDA Product Code
QJF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4550 FDA 510(k)
Regulation Number
878.4550 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Swift Ray 1 is an Autofluorescence Imaging Adjunct Tool for Wounds, classified as a Class II medical device under FDA regulation 878.4550. This handheld device employs hyperspectral imaging technology to capture bacterial fluorescence, infrared thermography, and medical-grade photographs, enabling clinicians to visualize wound conditions and bacterial presence using violet light and thermal mapping. Designed as a portable adjunct, it aids in assessing skin and wound health by revealing subclinical details otherwise invisible to standard visual inspection.

The device is supplied as a standalone handheld unit that attaches wirelessly to a smartphone camera, interfacing with companion software for data analysis. It is intended for single-use applications in clinical settings, including general and plastic surgery, though regulatory status and sterility requirements are not specified in the provided data. The Swift Ray 1 operates without MRI compatibility constraints and is assigned FDA 510(k) clearance (K251678) under the Substantial Equivalence determination. No third-party review or reprocessing is indicated, and storage conditions are not detailed in the specifications.

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: The Swift Ray 1, New pocket-sized device for clinicians could help them spot ... - Swift, Swift Medical Launches the World's First All-in-One Hyperspectral ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Swift Medical, Inc.

Sources (1)

  • FDA 510(k) K251678 24 fields · synced Sep 20, 2026