# K102595: Medistim Veriqc System

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Stim Asa
- Decided: Dec 27, 2010 after 109 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- 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: 3 generations back to K872048 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040228: Medi-Stim Veriq System, Model VQ1001 - VQ4122, Medi-Stim A/S (2004) Summary page 1.
- K041552: GE Vivid 7 BT04, General Electric Co. (2004) Summary page 1.

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0410-2026: Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules repla

## Indications for use
The Medi-Stim VeriQC System is intended for use as an intraoperative system utilizing ultrasonography to visualize blood flow and to guide surgeons to successfully pian and accomplish surgical interventions." The clinical indications for the device are: I. Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery. 2. Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures. 3. Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures. 4. Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures. 5. Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.

Source page: https://510kreport.com/device/K102595
Methodology: https://510kreport.com/methodology