# K230734: Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)

- Pathway: 510(k) (Traditional)
- Applicant: Precision Healing, LLC
- Decided: Dec 5, 2023 after 264 days
- Product code: QJF (Autofluorescence Imaging Adjunct Tool For Wounds)
- Device class: 2
- Regulation: 21 CFR 878.4550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K070426 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180008: Wound Autofluorescence Imaging Device Summary page 6.
- K131596: Wound Measuring & Monitoring Device, Woundvision, LLC (2013) Summary page 6.

## Indications for use
The MSI is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to: • View and digitally record images of a wound. • Measure and digitally record the size of a wound. • View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. • View and digitally record thermal images of a wound. The MSI does not diagnose or treat skin wounds.

Source page: https://510kreport.com/device/K230734
Methodology: https://510kreport.com/methodology