The following data is part of a premarket notification filed by Quest Medical Imaging with the FDA for Artemis Hand Held Imaging System.
| Device ID | K143474 |
| 510k Number | K143474 |
| Device Name: | Artemis Hand Held Imaging System |
| Classification | Confocal Optical Imaging |
| Applicant | QUEST MEDICAL IMAGING INDUSTRIEWEG 41 Middenmeer, NL 1775 Pw |
| Contact | Martin Heuvelmans |
| Correspondent | Martin Heuvelmans QUEST MEDICAL IMAGING INDUSTRIEWEG 41 Middenmeer, NL 1775 Pw |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-12-05 |
| Decision Date | 2015-06-30 |
| Summary: | summary |