K253303 is an FDA 510(k) clearance for the Dendrite Imaging System. This device is classified as a Parathyroid Autofluorescence Imaging Device (Class II - Special Controls, product code QDG).
Submitted by Dendrite Imaging, Inc. (Berkeley, US). The FDA issued a Cleared decision on November 28, 2025, 60 days after receiving the submission on September 29, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4550. 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..
| 510(k) Number | K253303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2025 |
| Decision Date | November 28, 2025 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QDG - Parathyroid Autofluorescence Imaging Device |
| 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. |