Cleared Traditional

K102123 - VIZION DR

K102123 is an FDA 510(k) clearance for VIZION 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 179-day FDA review.

K102123 · Viztek, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
179d
Days
Class 2
Risk

K102123 is an FDA 510(k) clearance for the VIZION DR. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Viztek, Inc. (Naples, US). The FDA issued a Cleared decision on January 24, 2011 after a review of 179 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K102123

510(k) Number K102123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2010
Decision Date January 24, 2011
Days to Decision 179 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
72d slower than avg
Panel avg: 107d · This submission: 179d
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 338
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K102123.
BRIVO XR385
K103448 · Ge Medical Systems, LLC · Aug 2011
CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K101779 · Jpi Healthcare Co, Ltd. · May 2011
PRESTODR 4143
K110849 · Cmt Medical Technologies, Ltd. · Apr 2011
KRYSTALRAD 560 (FLAATZ 560)
K102284 · Medicatech USA · Jan 2011
KRYSTALRAD (ATAL8)
K102285 · Medicatech USA · Jan 2011
DIGITAL DIAGNOSTIC X-RAY SYSTEM
K102408 · DRGEM Corporation · Dec 2010
K102123 · VIZION DR
Download PDF FDA Summary Viztek, Inc.