Cleared Traditional

K982146 - PICTOOLS MEDICAL TOOL KIT MODEL 1.0

K982146 is an FDA 510(k) clearance for PICTOOLS MEDICAL TOOL KIT MODEL 1.0, manufactured by Pegasus Imaging Corp.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K982146 · Pegasus Imaging Corp. · Radiology device
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Sep 1998
Decision
89d
Days
Class 2
Risk

K982146 is an FDA 510(k) clearance for the PICTOOLS MEDICAL TOOL KIT MODEL 1.0. 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 Pegasus Imaging Corp. (Tampa, US). The FDA issued a Cleared decision on September 14, 1998 after a review of 89 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 Pegasus Imaging Corp. devices

FDA 510(k) Submission Details - K982146

510(k) Number K982146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date September 14, 1998
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
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 Peers - LLZ System, Image Processing, Radiological

All 1328
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K982146.
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INSTACINE D-2000
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K982120 · Trex Medical Corp. · Sep 1998
PEDIATRIC INSTATRAK SYSTEM
K981998 · Visualization Technology, Inc. · Aug 1998
PRO VISION
K980648 · Algotec Systems, Ltd. · Jul 1998