# K221499: Minimally Invasive Prostate Surgery Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Augment Intelligent Medical System (China) Co., Ltd.
- Decided: Nov 22, 2022 after 183 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: 7 generations back to K954678 (1996). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162474: Artemis, Eigen (2016) Summary page 4.

## Most influential descendants
- K242314: Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2) (2025), 0 descendants of its own

## Indications for use
Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for use by the trained physician or urologist to perform the computer-assisted prostate surgical procedures through transperineal skin under real-time transrectal ultrasound guidance. It provides the capability to register and fuse with MRI medical images in DICOM format. It provides real-time 3D visualization and localization for prostate, biopsy needle, and probe. It also provides the ability to display an image coordinates and guidewire that means the current and the projected future path of the biopsy needle. Other software feature include patient data management, prostate and tumor modeling, 3D image registration. Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for treatment planning and guidance for prostate surgical procedures in a clinical setting.

Source page: https://510kreport.com/device/K221499
Methodology: https://510kreport.com/methodology