# K163339: Spectralmd Deepview Wound Imaging System 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Spectralmd, Inc.
- Decided: Aug 17, 2017 after 262 days
- Product code: DPT (Probe, Blood-Flow, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K905232 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124049: Deepview Digital Video Physiological Portable Imaging System, Spectralmd, Inc. (2013) Summary page 4.
- K123216: Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand, Including 4-Wheeled Stand Base an, Aimago SA (2013) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K163339
Methodology: https://510kreport.com/methodology