Cleared Traditional

K171222 - Vitrea Software Toshiba Package

Also marketed or referenced as:
VSTP-001A

K171222 is an FDA 510(k) clearance for Vitrea Software Toshiba Package, manufactured by Toshibamedical Systems Corporation. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K171222 · Toshibamedical Systems Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
43d
Days
Class 2
Risk

K171222 is an FDA 510(k) clearance for the Vitrea Software Toshiba Package. 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 June 8, 2017 after a review of 43 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 Toshibamedical Systems Corporation devices

FDA 510(k) Submission Details - K171222

510(k) Number K171222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2017
Decision Date June 08, 2017
Days to Decision 43 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
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

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 1837
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K171222.
SUITESTENSA
K163668 · Ebit Srl · Jun 2017
EchoPAC Software Only, EchoPAC Plug-in
K170847 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 2017
syngo Application Software
K170747 · Siemens Medical Solutions USA, Inc. · Jun 2017
SmartTarget
K170250 · Smarttarget, Ltd. · Jun 2017
syngo Dynamics Version VA30
K171053 · Siemens Healthcare GmbH · Jun 2017
AmCAD-US
K162574 · Amcad Biomed Corporation · May 2017