Cleared Traditional

K163339 - SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
(FDA 510(k) Clearance)

K163339 · Spectralmd, Inc. · Cardiovascular

Aug 2017

Decision

262d

Days

Class 2

Risk

K163339 is an FDA 510(k) clearance for the SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0. This device is classified as a Probe, Blood-flow, Extravascular (Class II — Special Controls, product code DPT).

Submitted by Spectralmd, Inc. (Dallas, US). The FDA issued a Cleared decision on August 17, 2017, 262 days after receiving the submission on November 28, 2016.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2120.

Submission Details

510(k) Number	K163339 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2016
Decision Date	August 17, 2017
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF