Cleared Traditional

K083084 - CT BRAIN PERFUSION FOR ZIOSTATION

K083084 is an FDA 510(k) clearance for CT BRAIN PERFUSION FOR ZIOSTATION, manufactured by Ziosoft, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K083084 · Ziosoft, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
64d
Days
Class 2
Risk

K083084 is an FDA 510(k) clearance for the CT BRAIN PERFUSION FOR ZIOSTATION. 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. (Redwood City, US). The FDA issued a Cleared decision on December 19, 2008 after a review of 64 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.

FDA 510(k) Submission Details - K083084

510(k) Number K083084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2008
Decision Date December 19, 2008
Days to Decision 64 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
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K083084.
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
K082526 · Mri Cardiac Services, Incorporated · Jan 2009
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · Carestream Health, Inc. · Dec 2008
IMAGE-ARENA APPLICATIONS
K083348 · Tomtec Imaging Systems GmbH · Dec 2008
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
K083555 · Emsoma Co., Ltd. · Dec 2008
VISAGE PACS, VERSION 6.0/CS 3.1
K082269 · Visage Imaging, Inc. · Dec 2008
MRI-PLAQUE VIEW, VERSION 1.1.2003
K082607 · Vpdiagnostics, Inc. · Dec 2008
K083084 · CT BRAIN PERFUSION FOR ZIOSTATION
Download PDF FDA Summary Ziosoft, Inc.