K230734 is an FDA 510(k) clearance for the Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009), a Autofluorescence Imaging Adjunct Tool For Wounds (Class II — Special Controls, product code QJF), submitted by Precision Healing, LLC (Fort Worth, US). The FDA issued a Cleared decision on December 5, 2023, 264 days after receiving the submission on March 16, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4550.
| 510(k) Number | K230734 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 16, 2023 |
| Decision Date | December 05, 2023 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QJF — Autofluorescence Imaging Adjunct Tool For Wounds |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4550 |
| Definition | An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis. |