510(k) · Cleared
ClearedDeepX DermoSight Dermatoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deepx Health, LLC · PSN Light Based Imaging
Cleared on May 17, 2023 as substantially equivalent to K192829 (Barco N.V., 2019) and 1 other predicate after an 85-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- May 17, 2023
- Review
- 85 days
- Class
- Class II
- Product code
- PSN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010259 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 3 generations backK032760 Apax Pacs SystemTis, Inc. · 2003
- 2 generations backK040171 Microderm, Model/Version 3.5Visiomed AG · 2004
- 1 generation backK192829 Demetra BDEM-01 DermatoscopeBarco N.V. · 2019
- This deviceK230448 DeepX DermoSight DermatoscopeDeepx Health, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −3 | K032760 | Apax Pacs System | Tis, Inc. | 2003 | — |
| −2 | K040171 | Microderm, Model/Version 3.5 | Visiomed AG | 2004 | — |
| −1 | K192829 | Demetra BDEM-01 Dermatoscope | Barco N.V. | 2019 | — |
| 0 (this device) | K230448 | DeepX DermoSight Dermatoscope | Deepx Health, LLC | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PSN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PSN device
- #1 K213957 Demetra Dermatoscope BDEM-01score 3.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192829 | Demetra BDEM-01 DermatoscopeSummary page 4…: 21 CFR 878.4580 Predicate Devices: Primary Predicate Demetra BDEM-01 Surgical Lamp [510(k) K192829] Reference Predicate Visiomed AG MicroDERM® Model/Version 3.5… | 2019 |
| * | K040171 | Microderm, Model/Version 3.5Summary page 4…[510(k) K192829] Reference Predicate Visiomed AG MicroDERM® Model/Version 3.5 [510(k) K040171] 1 Indications for Use: The DeepX Derm… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K192829.
How does its category compare?
All PSN devicesPSN Light Based Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PSN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PSN
Too few PSN 510(k)s in any year since 2007 to give a median.
Recalls per year · PSN
No recall names PSN since 2007.
Adverse event reports per year · PSN
No MAUDE report names PSN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DeepX DermoSight Dermatoscope is a non-invasive skin imaging system, which acquires white light dermatoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230448: DeepX DermoSight Dermatoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230448
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026