K242314 is an FDA 510(k) clearance for the Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Augment Intelligent Medical System (China) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on September 11, 2025, 402 days after receiving the submission on August 5, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K242314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2024 |
| Decision Date | September 11, 2025 |
| Days to Decision | 402 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |