Cleared Traditional

K082684 - 4D VIEWER RADIOLOGY

K082684 is the FDA 510(k) clearance for 4D VIEWER RADIOLOGY by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K082684 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
29d
Days
Class 2
Risk

K082684 is an FDA 510(k) clearance for the 4D VIEWER RADIOLOGY, MODEL USWP-100A. 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 Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on October 14, 2008 after a review of 29 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K082684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date October 14, 2008
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 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 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K082684.
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · Siemens Medical Solutions USA, Inc. · Jan 2009
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · Carestream Health, Inc. · Dec 2008
SYNGO IMAGING XS
K082430 · Siemens AG Medical Solutions · Nov 2008
COLOR LCD MONITOR
K082663 · Eizo Nanao Corporation · Oct 2008
AW SERVER
K081985 · Ge Medical Systems, LLC · Sep 2008
ULTRAEXTEND USWS-900A
K082596 · Toshiba America Medical Systems, In.C · Sep 2008