# K190314: Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

- Pathway: 510(k) (Traditional)
- Applicant: Mednovel Technology, Ltd.
- Decided: Oct 9, 2019 after 238 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K935595 (1995). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081148: Siemens Acuson 2000 Ultrasound System with Abvs Transducer, Siemens Medical Solutions USA, Inc., Ultrasound DI (2008) Summary page 4.
- K141870: Breast Volume Navigator, Metritrack, LLC (2014) Summary page 4.
- K963807: Tomtec Echo-Scan, Tomtec Imaging Systems, Inc. (1996) Summary page 5.

## Indications for use
The MedNovel Model AiVUS 1000 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of patient’s breast when used with an automatic scanning linear array probe. The device is not intended to be used as a replacement for mammography. It is an adjunct (add on) accessory for existing ultrasound imaging systems and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The MedNovel Model AiVUS 1000 system is capable of visually reconstructing the ultrasonic images for review with DICOM type files which will assist the doctor in making diagnoses of any abnormalities detected.

Source page: https://510kreport.com/device/K190314
Methodology: https://510kreport.com/methodology