Cleared Traditional

K082494 - DRAD3000E/RADREX-I (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082494 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
14d
Days
Class 2
Risk

K082494 is an FDA 510(k) clearance for the DRAD3000E/RADREX-I. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on September 12, 2008 after a review of 14 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 Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K082494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2008
Decision Date September 12, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 420
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K082494.
Lux HD 2530 detector (Lux HD 2530)
K252911 · Iray Imaging Technology (Haining) Limited · Oct 2025
Yushan X-Ray Flat Panel Detector
K250211 · Innocare Optoelectronics Corp. · Jul 2025
SKR 3000
K250665 · Konica Minolta, Inc. · Jun 2025
Wireless/ Wired X-Ray Flat Panel Detectors
K243734 · Allengers Medical Systems Limited · Apr 2025
EXPD 114
K242770 · DRTECH Corporation · Mar 2025
EXPD 4343N1
K243443 · DRTECH Corporation · Mar 2025