Cleared Traditional

K992886 - POWERVIEW ULTRASOUND WORKSTATION

K992886 is the FDA 510(k) clearance for POWERVIEW ULTRASOUND WORKSTATION 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 75-day FDA review.

K992886 · Toshiba America Medical Systems, In.C · Radiology device
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Nov 1999
Decision
75d
Days
Class 2
Risk

K992886 is an FDA 510(k) clearance for the POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A. 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 November 9, 1999 after a review of 75 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 K992886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1999
Decision Date November 09, 1999
Days to Decision 75 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
32d faster than avg
Panel avg: 107d · This submission: 75d
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 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 K992886.
INTURIS SUITE
K994210 · Philips Medical Systems, Inc. · Feb 2000
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K993227 · Philips Medical Systems North America, Inc. · Dec 1999
AX WORKSTATION DR-VIEWER SOFTWARE OPTION
K992925 · Siemens Corp. · Nov 1999
AX WORKSTATION
K992073 · Siemens Medical Solutions USA, Inc. · Sep 1999
GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C
K991629 · Ge Medical Systems, Inc. · Aug 1999
WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
K991626 · Analogic Corp. · Jul 1999