# K241975: Serv Medical CDSS

- Pathway: 510(k) (Traditional)
- Applicant: Serv Medical Pte., Ltd.
- Decided: Mar 17, 2025 after 255 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K896095 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192692: Brainomix 360 e-CTA, Brainomix Limited (2020) Summary page 5.

## Indications for use
SERV MEDICAL CDSS is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. The software runs on standard “off-the-shelf” hardware and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices. SERV MEDICAL CDSS provides viewing and analysis capabilities for imaging datasets acquired with DSA (Digital Subtraction Angiography). SERV MEDICAL CDSS is not intended for mobile diagnostic use.

Source page: https://510kreport.com/device/K241975
Methodology: https://510kreport.com/methodology