Cleared Traditional

K052895 - FOURSIGHT VIEWTOOL IMAGE VIEWER

K052895 is an FDA 510(k) clearance for FOURSIGHT VIEWTOOL IMAGE VIEWER, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K052895 · Siemens Medical Solutions USA, Inc. · Radiology device
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Oct 2005
Decision
13d
Days
Class 2
Risk

K052895 is an FDA 510(k) clearance for the FOURSIGHT VIEWTOOL IMAGE VIEWER. 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 Siemens Medical Solutions USA, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 27, 2005 after a review of 13 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K052895

510(k) Number K052895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2005
Decision Date October 27, 2005
Days to Decision 13 days
Submission Type Traditional
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
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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

Regulatory Technology Services, LLC
MARK JOB

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 1798
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K052895.
ADVANTAGE WORKSTATION 4.3.
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MIM 3.5 (CIRCA)
K052379 · Mimvista Corp. · Oct 2005
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)
K052775 · Siemens AG Medical Solutions · Oct 2005
REFORMAT GATEWAY
K052284 · Infinitt Co., Ltd. · Oct 2005
WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
K052312 · Wide Corporation · Oct 2005
ETIAM STAR PACS COMPONENTS
K052358 · Etiam, S.A. · Oct 2005