510(k) · Cleared
ClearedCortex Dermascan C Ultrasonic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cortex Technology Aps · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 17, 1999 as substantially equivalent to K894834 (Brymill Corp., 1989) after a 132-day review. Its family tree reaches back 1 generation to 1989. 17 later devices descend from it.
- Decided
- Mar 17, 1999
- Review
- 132 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894834 (1989). 17 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK894834 Dermascan C, an Ultrasonic Diagnostic SystemBrymill Corp. · 1989
- This deviceK983945 Cortex Dermascan C Ultrasonic SystemCortex Technology Aps · 1999
- Descendant · cites it directly · 16 of its ownK132028 Ulthera SystemUlthera, Inc. · 2013
- Descendant · 2 generations on · 15 of its ownK134032 Ulthera SystemUlthera, Inc. · 2014
- Descendant · 3 generations on · 13 of its ownK180623 Ulthera SystemUlthera, Inc. · 2018
- Descendant · 4 generations on · 8 of its ownK211483 SofWave SystemSofwave Medical, Ltd. · 2021
- Descendant · 5 generations on · 7 of its ownK223237 SofWave SystemSofwave Medical, Ltd. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K132028Ulthera SystemUlthera, Inc. · 2013 · cites it directly16descendants
- K134032Ulthera SystemUlthera, Inc. · 2014 · 2 generations on15descendants
- K180623Ulthera SystemUlthera, Inc. · 2018 · 3 generations on13descendants
- K211483SofWave SystemSofwave Medical, Ltd. · 2021 · 4 generations on8descendants
- K223237SofWave SystemSofwave Medical, Ltd. · 2022 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894834 | Dermascan C, an Ultrasonic Diagnostic System | Brymill Corp. | 1989 | — |
| 0 (this device) | K983945 | Cortex Dermascan C Ultrasonic System | Cortex Technology Aps | 1999 | — |
| +1 | K132028 | Ulthera System | Ulthera, Inc. | 2013 | — |
| +2 | K134032 | Ulthera System | Ulthera, Inc. | 2014 | — |
| +3 | K180623 | Ulthera System | Ulthera, Inc. | 2018 | — |
| +4 | K211483 | SofWave System | Sofwave Medical, Ltd. | 2021 | — |
| +5 | K223237 | SofWave System | Sofwave Medical, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K894834 | Dermascan C, an Ultrasonic Diagnostic SystemSummary page 1…3) Equivalent legally-marketed devices. The Derma-Scan C is identical to the version currently cleared in the United States, the DermaScan C Ultrasonic 3D skin scanner, K894834, assigned to the Brymill Corporation. (4) Description Derma Scan C Page A S5 The Dermascan C transducer is a si… | 1989 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132028 | Ulthera System | 2013 | 16 |
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 IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The DermaScan C ultrasonic transducer is intended to be used with the Cortex DermaScan C, an ultrasonic scanning system intended to be used to visualize the layers of the skin, including blood vessels, and to make approximate measurements of dimensions in the layers of the skin and blood vessels, by ultrasonic means.
The DermaScan C is an ultrasonic scanning system intended to be used to visualize the layers of the skin, including blood vessels, and to make approximate measurements of dimensions in the layers of the skin and blood vessels, by ultrasonic means.
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/K983945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983945: Cortex Dermascan C Ultrasonic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983945
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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