510(k) · Cleared
ClearedSiascope V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astron Clinica Limited · PSN Light Based Imaging
Cleared on Sep 14, 2007 as substantially equivalent to K023729 (Astron Clinica Limited, 2003) after a 366-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Sep 14, 2007
- Review
- 366 days
- Class
- Class II
- Product code
- PSN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023729 (2003). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K201408Demetra Analytics ToolkitBarco N.V. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023729 | Siascope II | Astron Clinica Limited | 2003 | — |
| 0 (this device) | K062736 | Siascope V | Astron Clinica Limited | 2007 | — |
| +1 | K201408 | Demetra Analytics Toolkit | Barco N.V. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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 K230448 DeepX DermoSight Dermatoscopescore 6.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K023729 | Siascope IISummary page 5…the software algorithms and theory of SlAscopy is the same as found in the predicate device. We assert that the SiAscope V substantially equivalent to the SlAscope II (K023729) Summary comparison of features and specification SiAscope V vs. SlAscope Il Parameter SlAscope V SlAscope Il (K023729) Product… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201408 | Demetra Analytics Toolkit | 2021 | 0 |
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?
How does its category compare?
All PSN devicesPSN Light Based Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 SlAscope is a non-invasive skin analysis system, which provides color bitmaps called 'SlAscans’ that show the relative location of blood, collagen and pigment'.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062736: Siascope V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062736
Report an extraction error
Are you the manufacturer?
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