Cleared Traditional

K954200 - VOXGRAM

K954200 is an FDA 510(k) clearance for VOXGRAM, manufactured by Voxel. The device is a Class 1 Radiology device with product code IWZ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K954200 · Voxel · Radiology device
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Sep 1995
Decision
23d
Days
Class 1
Risk

K954200 is an FDA 510(k) clearance for the VOXGRAM. Classified as Film, Radiographic (product code IWZ), Class I - General Controls.

Submitted by Voxel (Laguna Hills, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1840 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Voxel devices

FDA 510(k) Submission Details - K954200

510(k) Number K954200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date September 29, 1995
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

IWZ Device Classification - Class 1, General Controls

Product Code IWZ Film, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1840
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IWZ Film, Radiographic

All 21
Devices cleared under the same product code (IWZ) and FDA review panel - the closest regulatory comparables to K954200.
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