Cleared Abbreviated

K051745 - ECHOSYSTEM

K051745 is an FDA 510(k) clearance for ECHOSYSTEM, manufactured by Medstrat, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Abbreviated 510(k) pathway after a 15-day FDA review.

K051745 · Medstrat, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
15d
Days
Class 2
Risk

K051745 is an FDA 510(k) clearance for the ECHOSYSTEM. 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 Medstrat, Inc. (Downers Grove, US). The FDA issued a Cleared decision on July 14, 2005 after a review of 15 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Incremental AI imaging tool. Standards-verified equivalence. 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 - K051745

510(k) Number K051745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2005
Decision Date July 14, 2005
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
SILVIA ANKOVA

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 2285
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K051745.
MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE
K051528 · Mevis Technology GmbH & Co. KG · Jul 2005
XELERIS 2 PROCESSING AND REVIEW WORKSTATION
K051673 · GE Medical Systems · Jul 2005
19-INCH (48CM) COLOR LCD MONITOR CDL1904A
K051403 · Totoku Electric Co., Ltd. · Jul 2005
FUJI SYNAPSE WORKSTATION SOFTWARE
K051553 · Fujifilm Medical Systems U.S.A, Inc. · Jul 2005
BTI-SCAN, VERSION 4.0
K051392 · B.T.I. Biotechnology Institute, Sl. · Jun 2005
IMAGEQUBE PACS
K051037 · Intuitive Imaging Informatics, LLC · Jun 2005
K051745 · ECHOSYSTEM
Download PDF FDA Summary Medstrat, Inc.