# K143474: Artemis Hand Held Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical Imaging
- Decided: Jun 30, 2015 after 207 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944261 (1994). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110480: Pde Photodynamic Eye, Hamamatsu Photonics K.K. (2012) Summary page 4.
- K132475: Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System, Fluoptics (2014) Summary page 4.

## Recalls of this device
- Sep 24, 2024 · Class II · Z-0232-2025: Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requ

## Indications for use
The Artemis Handheld Imaging System is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, reconstructive and organ transplant surgeries. The system uses direct visualization for open procedures, or via a laparoscope for minimally invasive procedures.

Source page: https://510kreport.com/device/K143474
Methodology: https://510kreport.com/methodology