Cleared Traditional

K082347 - DIGITAL RADIOGRAPHY, FLEXDR C30

K082347 is an FDA 510(k) clearance for DIGITAL RADIOGRAPHY, manufactured by Konica Minolta Technoproduct Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K082347 · Konica Minolta Technoproduct Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
95d
Days
Class 2
Risk

K082347 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY, FLEXDR C30. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Konica Minolta Technoproduct Co., Ltd. (New York, US). The FDA issued a Cleared decision on November 18, 2008 after a review of 95 days - within the typical 510(k) review window.

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.

View all Konica Minolta Technoproduct Co., Ltd. devices

FDA 510(k) Submission Details - K082347

510(k) Number K082347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2008
Decision Date November 18, 2008
Days to Decision 95 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
12d faster than avg
Panel avg: 107d · This submission: 95d
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 298
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K082347.
CARESTREAM DRX-1 SYSTEM
K090318 · Carestream Health, Inc. · Apr 2009
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
K090623 · Canon USA, Inc. · Mar 2009
WIRELESS PORTABLE DETECTOR FD-W17
K090625 · Philips Medical Systems North America Co. · Mar 2009
DRAD3000E/RADREX-I
K082494 · Toshiba America Medical Systems, In.C · Sep 2008
DIGITAL RADIOGRAPHY CXDI-60G
K081648 · Canon, Inc. · Jun 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K081624 · Toshiba America Medical Systems, In.C · Jun 2008