Cardiovascular · 510(k) · 2017
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
SPECTRALMD, INC.. Cleared by FDA on 17 August 2017 under submission K163339, product code DPT (probe, blood-flow, extravascular). What FDA's record says, in FDA's words.
Device record · K163339
- Device. SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0DEVICE
- Company. SPECTRALMD, INC.COMPANY
- Decision. 17 August 2017, 510(k), substantially equivalent (traditional review); received 28 November 2016DECISION
- Panel. CardiovascularPANEL
- Product code. DPT, Probe, Blood-Flow, ExtravascularCODE
- Regulation. 21 CFR 870.2120, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The SpectralMD DeepView Wound Imaging System 2.0 is an optical imaging device intended for studies of blood flow in the microcirculation. The DeepView System is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery and anesthetics. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery), chronic wounds, decubitus ulcers, and diabetic ulcers.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 408 reports filed against devices carrying product code DPT. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
21 September 2026 · Malfunction · Medex Transtar Pressure Transducer · ICU Medical Healthcare Manufacturing S.A. de C.V. · report 9616567-2026-00033
It was reported that blood refluxed into the tubing after connecting the transducer to the radial artery catheter. After replacing the transducer, blood return and leakage stopped. There was a patient involvement and there were no additional adverse consequences.
18 September 2026 · Malfunction · Medex Transtar Pressure Transducer · ICU Medical Healthcare Manufacturing S.A. de C.V. · report 9616567-2026-00031
It was reported that blood was drawn via the right radial artery catheter. During flushing, leakage was observed at the sealed connection between the saline line and sensor. The consumable was replaced. There was a patient involvement and there were no additional adverse consequences.
18 September 2026 · Malfunction · Medex Transtar Pressure Transducer · ICU Medical Healthcare Manufacturing S.A. de C.V. · report 9616567-2026-00032
1 September 2026 · Malfunction · Medex Transtar Pressure Transducer · ICU Medical, Inc. · report 1526863-2026-00164
31 August 2026 · Malfunction · Medex Transtar Pressure Transducer · ICU Medical Healthcare Manufacturing S.A. de C.V. · report 9616567-2026-00014
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DPT, in Cardiovascular, from SPECTRALMD, INC., or cleared in 2017. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.