510(k) · Cleared
ClearedMultispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Healing, LLC · QJF Autofluorescence Imaging Adjunct Tool For Wounds
Cleared on Dec 5, 2023 as substantially equivalent to DEN180008 (unknown applicant, ) and 1 other predicate after a 264-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Dec 5, 2023
- Review
- 264 days
- Class
- Class II
- Product code
- QJF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K070426 (2007). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QJF device
- #1 K251678 Swift Ray 1score 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180008 | Wound Autofluorescence Imaging DeviceSummary page 6…Comparison For purposes of demonstrating substantial equivalence, the following predicate devices were selected: MolecuLight i:X by MolecuLight, Inc. authorized via DEN180008 WoundVision Scout (“WoundVision”) by WoundVision LLC cleared via K131596 Two predicate devices were selected in accordance… | |
| * | K131596 | Wound Measuring & Monitoring DeviceSummary page 6…predicate devices were selected: MolecuLight i:X by MolecuLight, Inc. authorized via DEN180008 WoundVision Scout (“WoundVision”) by WoundVision LLC cleared via K131596 Two predicate devices were selected in accordance with the guidance document entitled “The 510(k) Program: Evaluating Substantia… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All QJF devicesQJF Autofluorescence Imaging Adjunct Tool For Wounds: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QJF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJF
Too few QJF 510(k)s in any year since 2007 to give a median.
Recalls per year · QJF
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJF
No MAUDE report names QJF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230734: Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230734
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026