# K242314: Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2)

- Pathway: 510(k) (Traditional)
- Applicant: Augment Intelligent Medical System (China) Co., Ltd.
- Decided: Sep 11, 2025 after 402 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K954678 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221499: Minimally Invasive Prostate Surgery Navigation System, Augment Intelligent Medical System (China) Co., Ltd. (2022) Summary page 5.

## Indications for use
Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) is intended to guide trained urologists in the planning and positioning of insertion tools during the performance of trans-perineal prostate biopsies and interventional procedures under trans-rectal biplane ultrasound guidance. The procedures include clinical diagnosis and treatment of prostate conditions: biopsy, single or multi-needle ablation, and particle implantation. The device provides real-time 2D ultrasound scanning of the prostate to construct a 3D model and fuses it with the MRI 3D model, which can assist the surgeon in planning the puncture path avoiding the urethra and pubic bones. The device also provides a 3D simulation showing the current and planned puncture path of insertion tools such as biopsy needle and therapeutic needle, taking into account patient movement.

Source page: https://510kreport.com/device/K242314
Methodology: https://510kreport.com/methodology