Cleared Traditional

K082604 - VIZTEK DR, MODELS: DR1000, DR3000, DR4000

K082604 is an FDA 510(k) clearance for VIZTEK DR, manufactured by Viztek, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K082604 · Viztek, Inc. · Radiology device
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Nov 2008
Decision
74d
Days
Class 2
Risk

K082604 is an FDA 510(k) clearance for the VIZTEK DR, MODELS: DR1000, DR3000, DR4000. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Viztek, Inc. (Deer Field, US). The FDA issued a Cleared decision on November 21, 2008 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Viztek, Inc. devices

FDA 510(k) Submission Details - K082604

510(k) Number K082604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2008
Decision Date November 21, 2008
Days to Decision 74 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
33d faster than avg
Panel avg: 107d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 215
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K082604.
SEDECAL, MILLENNIUM PLUS
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DRAD30003/RADREX-I
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YSIO
K081722 · Siemens Medical Solutions USA, Inc. · Aug 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
K081836 · Carestream Health, Inc. · Jul 2008
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
K080553 · Vieworks Co., Ltd. · Apr 2008