Cleared Traditional

K043350 - MISTAR

K043350 is the FDA 510(k) clearance for MISTAR by Apollo Medical Imaging Technology Pty. , Ltd.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K043350 · Apollo Medical Imaging Technology Pty. , Ltd. · Radiology device
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Dec 2004
Decision
9d
Days
Class 2
Risk

K043350 is an FDA 510(k) clearance for the MISTAR, MODEL V3.2. 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 Apollo Medical Imaging Technology Pty. , Ltd. (Melbourne, Vic, AU). The FDA issued a Cleared decision on December 15, 2004 after a review of 9 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 Apollo Medical Imaging Technology Pty. , Ltd. devices

Submission Details

510(k) Number K043350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date December 15, 2004
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 1056
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K043350.
CENTRICITY PACS SYSTEM
K043415 · Ge Medical Systems Information Technologies · Jan 2005
MAMMOREPORT SOFTCOPY WORKSTATION
K042868 · Siemens Medical Solutions USA, Inc. · Jan 2005
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
K043333 · Vital Images, Inc. · Dec 2004
X-LEONARDO
K042995 · Siemens Medical Solutions USA, Inc. · Nov 2004
PHILIPS ORTHOPAEDIC APPLICATIONS
K042867 · Philips Medical Systems North America, Inc. · Nov 2004
CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
K042525 · Ge Medical Systems Information Technologies · Oct 2004