K230734
- 510(k) number
- K230734
- Device name
- Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
- Applicant
- Precision Healing, LLC TX · US
- Product code
- QJF — Autofluorescence Imaging Adjunct Tool For Wounds
- Decision date
- 2023-12-05
- Date received
- 2023-03-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K230734.pdf
Official FDA record: K230734
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.