510(k) · Cleared
ClearedMinimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augment Intelligent Medical System (China) Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Sep 11, 2025 as substantially equivalent to K221499 (Augment Intelligent Medical System (China) Co., Ltd., 2022) after a 402-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Sep 11, 2025
- Review
- 402 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954678 (1996). 13 ancestors in all, the oldest K953259 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 6 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 5 generations backK063107 3DNET SuiteBiotronics3D, Ltd. · 2006
- 4 generations backK081093 3-D Imaging WorkstationEigen, LLC · 2008
- 3 generations backK153073 UroNav (Version 2.0)Invivo Corporation · 2015
- 2 generations backK162474 ArtemisEigen · 2016
- 1 generation backK221499 Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd. · 2022
- This deviceK242314 Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris…Augment Intelligent Medical System (China) Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −7 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −6 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −5 | K063107 | 3DNET Suite | Biotronics3D, Ltd. | 2006 | — |
| −4 | K081093 | 3-D Imaging Workstation | Eigen, LLC | 2008 | — |
| −3 | K153073 | UroNav (Version 2.0) | Invivo Corporation | 2015 | — |
| −2 | K162474 | Artemis | Eigen | 2016 | — |
| −1 | K221499 | Minimally Invasive Prostate Surgery Navigation System | Augment Intelligent Medical System (China) Co., Ltd. | 2022 | — |
| 0 (this device) | K242314 | Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221499 | Minimally Invasive Prostate Surgery Navigation SystemSummary page 5…lation Class: Class 2 Panel: Radiology Product Code: LLZ Predicate Device 510(K) number: K221499 Minimally Invasive Prostate Surgery Navigation System(Model: Trade/Device Name:… | 2022 |
| † | K163121 | SmartUs EXT-1M/3M | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 13 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (122 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242314: Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242314
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026