Cleared Traditional

K242314 - Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242314 · Augment Intelligent Medical System (China) Co., Ltd. · Radiology device
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Sep 2025
Decision
402d
Days
Class 2
Risk

K242314 is an FDA 510(k) clearance for the Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2). Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Augment Intelligent Medical System (China) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on September 11, 2025 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Augment Intelligent Medical System (China) Co., Ltd. devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
295d slower than avg
Panel avg: 107d · This submission: 402d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2262
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