# K123565: Presto 1000 System

- Pathway: 510(k) (Traditional)
- Applicant: Physiosonics, Inc.
- Decided: Dec 13, 2012 after 23 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002533 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002533: TCD 100M, PWD13 Transducer, Spencer Technologies (2000) Summary page 1.

## Indications for use
The Presto 1000 transcranial Doppler ultrasound system is intended for use in the ICU and surgical suite as an ultrasound fluid flow analysis system for the monitoring of middle cerebral artery blood velocities. Vessels intended for monitoring are solely the MlI segments of the middle cerebral arteries via the temporal windows on the left and right sides of the head. The Presto 1000 calculates cerebrovascular flow index values to identify the presence of hemodynamically significant deviations from normal values. It records changes in these indices over time for later review, displays trends in user selected flow indices, and generates alerts when user selected indices exceed user defined levels, based on physician requirements and patient needs. The device is not intended to replace other means of evaluating vital patient physiological processes, such as pulse oximetry, electroencephalography or electrocardiography, is not intended to be used in fetal applications, and is not intended to be used in the sterile field.

Source page: https://510kreport.com/device/K123565
Methodology: https://510kreport.com/methodology