Cleared Special

K110801 - WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM

K110801 is an FDA 510(k) clearance for WV3000T DIGITAL X-RAY DIRECT IMAGING FL..., manufactured by Direct Digital Imaging Technology (Beijing), Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 132-day FDA review.

K110801 · Direct Digital Imaging Technology (Beijing), Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
132d
Days
Class 2
Risk

K110801 is an FDA 510(k) clearance for the WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Direct Digital Imaging Technology (Beijing), Inc. (Beijing, CN). The FDA issued a Cleared decision on August 2, 2011 after a review of 132 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110801

510(k) Number K110801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2011
Decision Date August 02, 2011
Days to Decision 132 days
Submission Type Special
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
25d slower than avg
Panel avg: 107d · This submission: 132d
Pathway characteristics
Modification to existing cleared device.

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 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K110801.
DIGITAL RADIOGRAPHY
K111682 · Canon Inc. -Medical Equipment Group · Sep 2011
DIGITAL RADIOGRAPHY
K112309 · Canon Inc. -Medical Equipment Group · Sep 2011
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
K111548 · Fujifilm Medical System U.S.A., Inc. · Aug 2011
SANTEVIEW
K111312 · Sehyun Co., Ltd. · Jul 2011
ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
K102479 · Alara, Inc. · Jun 2011
REGUIS SIGMA
K103703 · Konica Minolta Medical & Graphic, Inc. · Jun 2011
K110801 · WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
Download PDF FDA Summary Direct Digital Imagin…