Cleared Traditional

K163339 - SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0

K163339 is an FDA 510(k) clearance for SPECTRALMD DEEPVIEW WOUND IMAGING SYSTE..., manufactured by Spectralmd, Inc.. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K163339 · Spectralmd, Inc. · Cardiovascular device
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Aug 2017
Decision
262d
Days
Class 2
Risk

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

Submitted by Spectralmd, Inc. (Dallas, US). The FDA issued a Cleared decision on August 17, 2017 after a review of 262 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectralmd, Inc. devices

FDA 510(k) Submission Details - K163339

510(k) Number K163339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPT Probe, Blood-flow, Extravascular

All 31
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