K242314
- 510(k) number
- K242314
- Device name
- Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)
- Applicant
- Augment Intelligent Medical System (China) Co., Ltd. CN
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-09-11
- Date received
- 2024-08-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242314.pdf
Official FDA record: K242314
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.