# K163668: Suitestensa

- Pathway: 510(k) (Traditional)
- Applicant: Ebit Srl
- Decided: Jun 23, 2017 after 178 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: 12 generations back to K913770 (1991). 112 ancestors in all.
No later device cites it as a predicate yet.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160108: Synapse PACS, Fujifilm Medical Systems U.S.A, Inc. (2016) Summary page 4.

## Indications for use
SUITESTENSA is an integrated software system for the management and reporting of diagnostic-instrumental procedures in Cardiology and Radiology departments. It is intended to support and assist trained professionals in the diagnostic process, through the acquisition, storage, viewing, processing and reporting of cardiology and radiology imaging studies and ECG traces. SUITESTENSA also allows transfer of images to CD/DVD. SUITESTENSA may be used also for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography. SUITESTENSA is intended to be used by qualified professionals, i.e. doctors (radiologists, cardiologists, etc.), ward technicians, paramedics, administrative personnel, specialist ward doctors.

Source page: https://510kreport.com/device/K163668
Methodology: https://510kreport.com/methodology