Cleared Traditional

K173088 - Vitrea Software Toshiba Package VSTP-001A

K173088 is the FDA 510(k) clearance for Vitrea Software Toshiba Package VSTP-001A by Toshibamedical Systems Corporation. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K173088 · Toshibamedical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
124d
Days
Class 2
Risk

K173088 is an FDA 510(k) clearance for the Vitrea Software Toshiba Package VSTP-001A. 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 Toshibamedical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on January 31, 2018 after a review of 124 days - within the typical 510(k) review window.

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 Toshibamedical Systems Corporation devices

Submission Details

510(k) Number K173088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date January 31, 2018
Days to Decision 124 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
17d slower than avg
Panel avg: 107d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Toshiba America Medical Systems, In.C
Paul Biggins

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 1093
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K173088.
eUnity
K172490 · Client Outlook, Inc. · Feb 2018
Insight BD
K172832 · Siemens Medi Cal Solutions, Inc. · Feb 2018
MFI-Cardiac
K173512 · Multifunctional Imaging, LLC · Feb 2018
Arterys Oncology DL
K173542 · Arterys, Inc. · Jan 2018
Navigo Workstation Version 2.0
K173054 · UC-CARE , Ltd. · Jan 2018
CS Imaging
K173622 · Trophy · Jan 2018