# K983945: Cortex Dermascan C Ultrasonic System

- Pathway: 510(k) (Traditional)
- Applicant: Cortex Technology Aps
- Decided: Mar 17, 1999 after 132 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894834 (1989). 1 ancestor in all.
17 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894834: Dermascan C, an Ultrasonic Diagnostic System, Brymill Corp. (1989) Summary page 1.

## Most influential descendants
- K132028: Ulthera System (2013), 16 descendants of its own
- K134032: Ulthera System (2014), 15 descendants of its own
- K180623: Ulthera System (2018), 13 descendants of its own
- K211483: SofWave System (2021), 8 descendants of its own
- K223237: SofWave System (2022), 7 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K983945
Methodology: https://510kreport.com/methodology