# K040195: Calysto Image IV-Image and Information Management System

- Pathway: 510(k) (Traditional)
- Applicant: Witt Biomedical Corp
- Decided: Apr 7, 2004 after 70 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CALYSTO Image IV is an image and information management system intended for image data acquisition, archival, distribution, viewing and analysis for medical images of all modalities as well as Electrocardiogram (ECG) images. It's users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Image IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device. The CALYSTO ECG Management System is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO ECG Management System does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO ECG Management System provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Source page: https://510kreport.com/device/K040195
Methodology: https://510kreport.com/methodology