Cleared Traditional

K200315 - Ziostation2

K200315 is the FDA 510(k) clearance for Ziostation2 by Ziosoft, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K200315 · Ziosoft, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
88d
Days
Class 2
Risk

K200315 is an FDA 510(k) clearance for the Ziostation2. 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 Ziosoft, Inc. (Minato-Ku, JP). The FDA issued a Cleared decision on May 5, 2020 after a review of 88 days - a notably fast clearance cycle.

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 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 Ziosoft, Inc. devices

Submission Details

510(k) Number K200315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2020
Decision Date May 05, 2020
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 Consultant

Ziosoft USA, Inc.
Richard Ball

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1055
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K200315.
CariCloud
K200274 · Caristo Diagnostics · May 2020
syngo Ultrasound Apps Suite (sUSAS)
K201062 · Siemens Medical Solutions USA, Inc. · May 2020
AVIEW LCS
K193220 · Coreline Soft Co., Ltd. · May 2020
ZeeroMED View
K200546 · O3 Enterprise Srl · May 2020
Optimized Positioning System (OPS) Insight
K192656 · Corin USA · May 2020
ArthrexVIP Web Portal
K193523 · Arthrex, Inc. · Apr 2020