510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K110801Substantially Equivalent

Wv3000t Digital X-Ray Direct Imaging Flat Panel Detector System

Direct Digital Imaging Technology (Beijing), Inc., Beijing, CN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110801 is the FDA 510(k) clearance record for WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM, a class II device, cleared for Direct Digital Imaging Technology (Beijing), Inc. on under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)). FDA records list 2 510(k) clearances for Direct Digital Imaging Technology (Beijing), Inc., from to . As of , FDA records show no recalls naming K110801.

Clearance record

Decision date
Received
(132 days to decision)
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Direct Digital Imaging Technology (Beijing), Inc. #33 Bldg. Yuquan Wisdom Vale, Beijing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQB

Trailing 12 months
3 clearances under product code MQB in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20261
August 20260
September 20260
October 20260