Artemis Hand Held Imaging System— 510(k) K143474
Substantially EquivalentQuest Medical Imaging
FDA 510(k) clearance K143474 for Artemis Hand Held Imaging System, Substantially Equivalent on 2015-06-30. Applicant: Quest Medical Imaging. Device class: 2.
Clearance details
- Applicant
- Quest Medical Imaging
- Product code
- Code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Middenmeer, NL
Recent devices under product code OWN
view allMore clearances from Quest Medical Imaging
view allAdverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K143474
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143474.
Data sourced from openFDA. This site is unofficial and independent of the FDA.