# K200132: Ashvins

- Pathway: 510(k) (Traditional)
- Applicant: Medicalcommunications GmbH
- Decided: Feb 18, 2020 after 28 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K971684 (1997). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142750: JiveX, Visus Technology Transfer GmbH (2015) Summary page 5.
- K122938: Forum Forum Archive Forum Archive & Viewer Forum Assist Match, Carl Zeiss Meditec, AG (2012) Summary page 5.

## Recalls of this device
- Sep 9, 2025 · Class II · Z-2673-2025: Potential that the measured value may be smaller than the actual area.

## Indications for use
Ashvins is a modular software solution and is used for viewing, reporting, processing, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information. Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM “For Presentation” images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed. Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K200132
Methodology: https://510kreport.com/methodology