# K202119: AcuSee AS-P1000 System

- Pathway: 510(k) (Traditional)
- Applicant: Weipeng (Suzhou) Medical Devices Co., Ltd.
- Decided: Oct 7, 2020 after 69 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: 5 generations back to K882383 (1988). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141806: Clear Guide One, Clear Guide Medical (2014) Summary page 4.

## Indications for use
The AcuSee AS-P1000 system is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle and for predicting its future path on a display, which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualization. The AcuSee AS-P1000 system is intended to be used in a clinical setting.

Source page: https://510kreport.com/device/K202119
Methodology: https://510kreport.com/methodology