510(k) Report

De Novo · Granted

Granted

Wound Autofluorescence Imaging Device

DEN180008De NovoClass I21 CFR 878.4165

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unknown applicant · QCR Wound Autofluorescence Imaging Device

Granted as a new device type through De Novo. 1 later device descends from it.

Class
Class I
Product code
QCR
Recalls
None

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared
  1. This deviceDEN180008 Wound Autofluorescence Imaging Device ·
  2. Descendant · cites it directly · 0 of its ownK230734 Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager…Precision Healing, LLC · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K230734Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN180008Wound Autofluorescence Imaging Device—
+1K230734Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI)…Precision Healing, LLC2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of DEN180008, –2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K230734Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC20230

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?

  • Of its descendants, K230734 (Precision Healing, LLC, 2023) has gone furthest, with 0 descendants of its own.

https://510kreport.com/device/DEN180008 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN180008: Wound Autofluorescence Imaging Device.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180008

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026