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FDA PMA

Fluorescence imaging for breast cancer detection

PMA Number: P230014 · 2025-11-25

ApplicantLumicell, Inc.
Decision Date2025-11-25
PMA NumberP230014
Product CodeSAW
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeSU

Device Summary

Fluorescence imaging for breast cancer detection is the device name listed in this FDA 510(k) record. The listed applicant is Lumicell, Inc.. It received FDA 510(k) clearance on 2025-11-25. The device is classified under product code SAW. It was reviewed by the SU advisory panel.

Frequently Asked Questions

What is the Fluorescence imaging for breast cancer detection?

Fluorescence imaging for breast cancer detection is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Lumicell, Inc..

When did Fluorescence imaging for breast cancer detection receive FDA 510(k) clearance?

The clearance date for Fluorescence imaging for breast cancer detection can be found in the official FDA records.

Who is the listed applicant for Fluorescence imaging for breast cancer detection?

The FDA 510(k) record lists Lumicell, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluorescence imaging for breast cancer detection?

The FDA product code for Fluorescence imaging for breast cancer detection is SAW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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