Artemis Hand Held Imaging System
FDA 510(k) K143474 · Quest Medical Imaging
510(k) numberK143474
Submission
- Device name
- Artemis Hand Held Imaging System
- Applicant
- Quest Medical Imaging
Middenmeer, NL - Received
- December 5, 2014
- Decision date
- June 30, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
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Questions and answers
When was Artemis Hand Held Imaging System cleared by the FDA?
Artemis Hand Held Imaging System (K143474) received a 510(k) decision of Substantially Equivalent on June 30, 2015, 207 days after the submission was received.
What is the product code of K143474?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.