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SpectralMD DeepView Wound Imaging System 2.0

by Spectralmd, Inc.

510(k) K163339

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK163339 Date17 Aug 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DPT
Device Class
Class II
Regulation
21 CFR Part 870.2120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 SpectralMD DeepView Wound Imaging System 2.0 is a medical imaging device that uses non-contact photoplethysmography (PPG) technology to capture color images showing blood perfusion in tissues. It helps clinicians assess blood flow in a variety of clinical settings, including wound healing, plastic surgery, and vascular surgery, by providing detailed images of microcirculation in healthy or affected tissues.

The system is supplied as a medical device with FDA 510(k) clearance under product code DPT. It is designed for use in clinical settings to provide immediate wound healing prediction through multispectral imaging and artificial intelligence. The device helps clinicians obtain information not visible to the human eye to support assessment and treatment decisions.

Other devices from Spectralmd, Inc.

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the SpectralMD DeepView Wound Imaging System 2.0 used for?

    The SpectralMD DeepView Wound Imaging System 2.0 is a medical imaging device that uses non-contact photoplethysmography (PPG) technology to capture color images showing blood perfusion in tissues. It helps clinicians assess blood flow in wound healing, plastic surgery, and vascular surgery by providing detailed images of microcirculation in healthy or affected tissues.

  • How is the SpectralMD DeepView Wound Imaging System 2.0 supplied?

    The system is supplied as a medical device with FDA 510(k) clearance under product code DPT. It is designed for use in clinical settings to provide immediate wound healing prediction through multispectral imaging and artificial intelligence, helping clinicians obtain information not visible to the human eye to support assessment and treatment decisions.

  • What regulatory status does the SpectralMD DeepView Wound Imaging System 2.0 have?

    The SpectralMD DeepView Wound Imaging System 2.0 has FDA 510(k) clearance with product code DPT. It was received by the FDA on November 28, 2016, and received a decision of Substantially Equivalent on August 17, 2017, with K number K163339.

  • In what clinical settings can the SpectralMD DeepView Wound Imaging System 2.0 be used?

    The device can be used in a variety of clinical settings including wound healing, plastic surgery, and vascular surgery. It helps clinicians assess blood flow by providing detailed images of microcirculation in both healthy and affected tissues, supporting assessment and treatment decisions.