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SnapshotNIR Model KD205

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240601

by Kent Imaging Inc

Identifiers

510(k) Number
K240601 FDA 510(k)
FDA Product Code
MUD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SnapshotNIR Model KD205 is a near-infrared (NIR) oximeter designed to measure and map tissue oxygen saturation (StO₂), oxyhemoglobin, and deoxyhemoglobin levels in capillary networks. Classified as a tissue saturation oximeter, it provides visual imaging to assess tissue perfusion and oxygenation dynamics in clinical settings.

This non-contact, reflectance-based device is intended for single-use applications in wound care, limb preservation, and reconstructive surgery. Supplied sterile and regulated under FDA 510(k) clearance and MDR compliance, it requires no special storage conditions beyond standard medical device handling. The device operates in Class II (risk-based) regulatory classification and is authorized for use in cardiovascular and related specialties.

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: SnapshotNIR, a near-infrared medical imaging device — Kent Imaging, USER DOCUMENTATION - Kent Imaging, PDF WoundCare_KD205_MM-24001-12_01 - nhmedical.com

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kent Imaging Inc
FDA Applicant
Kent Imaging, Inc.

Sources (2)

  • FDA 510(k) K240601 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026