# K023414: Mida Algorithm Rev. B

- Pathway: 510(k) (Traditional)
- Applicant: Ortivus AB
- Decided: Dec 5, 2003 after 420 days
- Product code: DYC (Vectorcardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K872781 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896396: Mida System, Models 1000/1100, Medical Graphics Corp. (1990) Summary page 1.
- K992595: HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement, HP Viridia CMS 24/26, Rev K with, Hewlett-Packard GmbH (1999) Summary page 1.

## Indications for use
For use only by a digital device to measure ST-segment shifts. Assessment of real time ST segment analysis in adult patients. The MIDATm Algorithm Rev. B is intended for use in the hospital environment for the following patient population: Ages: 33-82 years Heights: 147 to 185cm (58 to 73 in.) Weights: 53 to 118kg (117 to 261 lbs.) Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) The use of EASI leads implies that the results may not be of diagnostic quality.

Source page: https://510kreport.com/device/K023414
Methodology: https://510kreport.com/methodology