Panels › General, Plastic Surgery › Product code PSN · Class 2
Light Based Imaging
Regulation 878.4580
0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PSN
| Company | 510(k)s | Recalls |
|---|---|---|
| Astron Clinica Limited | 3 | 0 |
| Barco N.V. | 3 | 0 |
| Caliber Imaging & Diagnostics, Inc. | 1 | 0 |
| Deepx Health, LLC | 1 | 0 |
| Lucid, Inc. | 1 | 0 |
| Visiomed AG | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2023 | K230448 | DeepX DermoSight Dermatoscope Deepx Health, LLC | PSN |
| Mar 11, 2022 | K213957 | Demetra Dermatoscope BDEM-01 Barco N.V., BE | PSN |
| Feb 18, 2021 | K201408 | Demetra Analytics Toolkit Barco N.V., BE | PSN |
| Dec 13, 2019 | K192829 | Demetra BDEM-01 Dermatoscope Barco N.V., BE | PSN |
| May 3, 2018 | K180162 | VivaScope System Caliber Imaging & Diagnostics, Inc. | PSN |
| Sep 17, 2008 | K080788 | VIVASCOPE SYSTEM, MODEL 1500, 3000 Lucid, Inc. | PSN |
| Sep 14, 2007 | K062736 | SIASCOPE V Astron Clinica Limited | PSN |
| Jun 8, 2004 | K040171 | MICRODERM, MODEL/VERSION 3.5 Visiomed AG | PSN |
| Feb 3, 2003 | K023729 | SIASCOPE II Astron Clinica Limited | PSN |
| Feb 20, 2002 | K011273 | SI ASCOPE Astron Clinica Limited | PSN |
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