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SnapshotNIR Model KD205

by Kent Imaging Inc

510(k) K240601

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240601↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK240601 Date2 Apr 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240601 decided 2 Apr 2024 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
MUD
FDA applicant
Kent Imaging, Inc.
Device class
Class II
Regulation
21 CFR Part 870.2700
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code MUD (Oximeter, Tissue Saturation).

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