MQB · Class II · 21 CFR 892.1680

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
49–72 of 421
Cleared Apr 01, 2022
Wireless Digital Flat Panel Detector
K220668
Iray Technology Taicang , Ltd.
Radiology · 25d
Cleared Mar 29, 2022
Focus HD 43 Detector
K213529
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Mar 29, 2022
Focus HD 35 Detector
K213646
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Feb 16, 2022
14HQ901G-B
K214044
Lg Electronics.Inc
Radiology · 51d
Cleared Feb 04, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
K220098
Canon, Inc.
Radiology · 23d
Cleared Jan 31, 2022
SKR 3000
K213908
Konica Minolta, Inc.
Radiology · 48d
Cleared Jan 24, 2022
DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
K213780
Canon, Inc.
Radiology · 53d
Cleared Jan 21, 2022
Universal DR 1748
K214030
Konica Minolta Healthcare Americas, Inc.
Radiology · 29d
Cleared Jan 14, 2022
Eclipse II with Smart Noise Cancellation
K213307
Carestream Health, Inc.
Radiology · 102d
Cleared Nov 18, 2021
VALORY
K213469
Agfa N.V.
Radiology · 21d
Cleared Nov 15, 2021
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
K213497
H&abyz Co., Ltd.
Radiology · 14d
Cleared Oct 18, 2021
0909FCB, 1212FCA
K212753
Rayence Co., Ltd.
Radiology · 48d
Cleared Sep 17, 2021
Intelligent NR
K212269
Canon, Inc.
Radiology · 59d
Cleared Sep 09, 2021
DIGITAL RADIOGRAPHY CXDI-Pro, D1
K212553
Canon, Inc.
Radiology · 27d
Cleared Aug 25, 2021
RFA-1717DIG, RFA-1717DIC
K212051
Astel, Inc.
Radiology · 56d
Cleared Aug 24, 2021
SKR 3000
K210619
Konica Minolta, Inc.
Radiology · 176d
Cleared Aug 23, 2021
6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
K212105
Pzmedical Technology Co., Ltd.
Radiology · 48d
Cleared Jul 30, 2021
DX-D Imaging Package with XD Detectors
K211790
Agfa N.V.
Radiology · 50d
Cleared Jul 09, 2021
PRIMO S
K211542
A.T.S. Applicazione Tecnologie Speciali S.R.L.
Radiology · 51d
Cleared Jun 04, 2021
Prudent 1717, Prudent 1417, Prudent 1212
K211108
Pixxgen Corporation
Radiology · 51d
Cleared Apr 30, 2021
AcuityDRe
K210919
Radmedix, LLC
Radiology · 32d
Cleared Apr 28, 2021
1717FCC
K210985
Rayence Co., Ltd.
Radiology · 27d
Cleared Apr 21, 2021
Yushan X-Ray Flat Panel Detector with DROC
K210988
Innocare Optoelectronics Corp.
Radiology · 20d
Cleared Apr 02, 2021
Eclipse II with Smart Noise Cancellation
K202441
Carestream Health, Inc.
Radiology · 219d