Artemis Light Engine
by Quest Medical Imaging 510(k)
Active
510(k) K141164
Overview
The Artemis Light Engine is a Led Light Source device intended for use in gastroenterology and urology procedures. It is classified as a Class 2 medical device under regulation number 876.1500 with product code NTN.
The device received FDA 510(k) clearance (K141164) on March 16, 2015, following a traditional review pathway. It was found to be substantially equivalent to a predicate device and is manufactured by Quest Medical Imaging in Akron, Ohio.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141164 | Date16 Mar 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NTN
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quest Medical Imaging
Questions
What is the ARTEMIS LIGHT ENGINE used for?
The ARTEMIS LIGHT ENGINE is a LED light source intended for use in gastroenterology and urology procedures, providing illumination during endoscopic examinations and interventions in these specialties.
How is the ARTEMIS LIGHT ENGINE supplied and is it reusable?
The ARTEMIS LIGHT ENGINE is supplied as a reusable LED light source device; it is not a single-use product and is designed for repeated use in clinical settings following manufacturer cleaning and maintenance guidelines.
What regulatory clearance does the ARTEMIS LIGHT ENGINE have?
The ARTEMIS LIGHT ENGINE received FDA 510(k) clearance under number K141164 on March 16, 2015, through a traditional review pathway, and was determined to be substantially equivalent to a predicate device.