SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0

K163339

SPECTRALMD, INC. · cleared 2017-08-17 · product code DPT · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The DeepView System 2.0 is a prescription device that utilizes the principles of non-contact photoplethysmography (PPG) to capture images of tissue blood perfusion. This is accomplished by measuring the optical properties of tissues and blood as they vary in response to changing hemodynamic conditions. The device's software combines real-time digital analysis based on the interaction of light with vascular tissues below the skin's surface to produce 2-D color images on a touch-screen display depicting relative blood perfusion. The DeepView System consists of a Camera Head with LED optics, an Articulating Arm for Camera Head positioning, a Touch-Screen Display for image viewing, and for accessing and interacting with the Graphical User Interface (GUI). All components are integrated on a Mobile Cart that houses the hardware/software, uninterruptable power supply (UPS), and allows for transport between use environments.”
Algorithmreal-time digital analysis based on the interaction of light with vascular tissues below the skin's surface to produce 2-D color images depicting relative blood perfusion
source quote (p.4)
“The device's software combines real-time digital analysis based on the interaction of light with vascular tissues below the skin's surface to produce 2-D color images on a touch-screen display depicting relative blood perfusion.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: detect pulsatile fluid flow; frequency detection; capability to detect pulsatile flow under conditions simulating physiological properties of blood flow in human tissues; identify the 2% alternating change (AC) modulation that is consistent with the tissue-volume change in human tissue resulting from blood flow; identify the AC modulations at various frequencies within the frequencies of the human heart rate; detect fluid flow beneath the surface of an optically dense medium

standards: AAMI/ANSI ES60601-1:2005/(R) 2012 & A1:2012, IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007, IEC 60601-1-2 (2007)/(R) 2012

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

22
recalls in product code, 24mo
67
MAUDE reports in code, 12mo
-17%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K163339