FDA Product Code MQB: Solid State X-ray Imager (flat Panel/digital Imager)
FDA product code MQB covers solid-state X-ray imagers, also known as flat panel detectors or digital image receptors.
These devices replace traditional film and computed radiography cassettes with direct digital capture of X-ray images. They provide higher image quality, lower radiation dose, and immediate image availability compared to conventional systems.
MQB devices are Class II medical devices, regulated under 21 CFR 892.1680 and reviewed by the FDA Radiology panel.
Leading manufacturers include Iray Technology Taicang , Ltd., Canon, Inc. and DRTECH Corporation.
421
Total
421
Cleared
80d
Avg days
1997
Since
421 devices
Cleared
Apr 01, 2022
Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Radiology
25d
Cleared
Mar 29, 2022
Focus HD 43 Detector
Iray Technology Taicang , Ltd.
Radiology
145d
Cleared
Mar 29, 2022
Focus HD 35 Detector
Iray Technology Taicang , Ltd.
Radiology
145d
Cleared
Feb 16, 2022
14HQ901G-B
Lg Electronics.Inc
Radiology
51d
Cleared
Feb 04, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
Canon, Inc.
Radiology
23d
Cleared
Jan 31, 2022
SKR 3000
Konica Minolta, Inc.
Radiology
48d
Cleared
Jan 24, 2022
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
Canon, Inc.
Radiology
53d
Cleared
Jan 21, 2022
Universal DR 1748
Konica Minolta Healthcare Americas, Inc.
Radiology
29d
Cleared
Jan 14, 2022
Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.
Radiology
102d
Cleared
Nov 18, 2021
VALORY
Agfa N.V.
Radiology
21d
Cleared
Nov 15, 2021
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
H&abyz Co., Ltd.
Radiology
14d
Cleared
Oct 18, 2021
0909FCB, 1212FCA
Rayence Co., Ltd.
Radiology
48d
Cleared
Sep 17, 2021
Intelligent NR
Canon, Inc.
Radiology
59d
Cleared
Sep 09, 2021
DIGITAL RADIOGRAPHY CXDI-Pro, D1
Canon, Inc.
Radiology
27d
Cleared
Aug 25, 2021
RFA-1717DIG, RFA-1717DIC
Astel, Inc.
Radiology
56d
Cleared
Aug 24, 2021
SKR 3000
Konica Minolta, Inc.
Radiology
176d
Cleared
Aug 23, 2021
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
Pzmedical Technology Co., Ltd.
Radiology
48d
Cleared
Jul 30, 2021
DX-D Imaging Package with XD Detectors
Agfa N.V.
Radiology
50d
Cleared
Jul 09, 2021
PRIMO S
A.T.S. Applicazione Tecnologie Speciali S.R.L.
Radiology
51d
Cleared
Jun 04, 2021
Prudent 1717, Prudent 1417, Prudent 1212
Pixxgen Corporation
Radiology
51d
Cleared
Apr 30, 2021
AcuityDRe
Radmedix, LLC
Radiology
32d
Cleared
Apr 28, 2021
1717FCC
Rayence Co., Ltd.
Radiology
27d
Cleared
Apr 21, 2021
Yushan X-Ray Flat Panel Detector with DROC
Innocare Optoelectronics Corp.
Radiology
20d
Cleared
Apr 02, 2021
Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.
Radiology
219d