Cleared Traditional

K103348 - DIGIVIEW 250

K103348 is an FDA 510(k) clearance for DIGIVIEW 250, manufactured by Kub Technologies, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K103348 · Kub Technologies, Inc. · Radiology device
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Oct 2011
Decision
339d
Days
Class 2
Risk

K103348 is an FDA 510(k) clearance for the DIGIVIEW 250. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Kub Technologies, Inc. (Milford, US). The FDA issued a Cleared decision on October 20, 2011 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kub Technologies, Inc. devices

FDA 510(k) Submission Details - K103348

510(k) Number K103348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2010
Decision Date October 20, 2011
Days to Decision 339 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
232d slower than avg
Panel avg: 107d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 260
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K103348.
REGIUS SIGMA2
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K111548 · Fujifilm Medical System U.S.A., Inc. · Aug 2011
REGUIS SIGMA
K103703 · Konica Minolta Medical & Graphic, Inc. · Jun 2011