Cleared Traditional

K022877 - OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM

K022877 is an FDA 510(k) clearance for OBSERVER ULTRASOUND REPORTING AND IMAGI..., manufactured by Vision Chips, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K022877 · Vision Chips, Inc. · Radiology device
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Feb 2003
Decision
159d
Days
Class 2
Risk

K022877 is an FDA 510(k) clearance for the OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM. 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 Vision Chips, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on February 5, 2003 after a review of 159 days - an extended review 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 Vision Chips, Inc. devices

FDA 510(k) Submission Details - K022877

510(k) Number K022877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2002
Decision Date February 05, 2003
Days to Decision 159 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 107d · This submission: 159d
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 1612
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