510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MQBClass II

Solid State X-Ray Imager (Flat Panel/Digital Imager)

21 CFR 892.1680 / Radiology
FDA source (opens on fda.gov)

MQB is the FDA product code for Solid State X-Ray Imager (Flat Panel/Digital Imager), a class II device type, regulated under 21 CFR 892.1680. As of , FDA records hold 424 510(k) clearances under this code, the most recent dated , and 195 recalls.

Classification record

Product code
MQB
Device name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
424
Ingested recalls
195

Clearances, product code MQB

By decision year
424 clearances under product code MQB with a decision year between 1997 and 2026, 2014 the highest year at 32.
Show the numbers
510(k) clearances under FDA product code MQB by decision year
YearClearances
19971
19983
19994
20004
20015
20028
20036
20046
200513
200616
200713
20088
200915
201011
201124
201222
201321
201432
201521
201622
201731
201816
201922
202019
202121
202231
202310
20248
20258
20263

Applicants with the most clearances

Product code MQB
Applicants holding the most 510(k) clearances under product code MQB
ApplicantClearances
Rayence Co., Ltd.29
Eastman Kodak Company19
DRTECH Corporation18
Iray Technology Taicang, Ltd.17
AGFA Healthcare Corp.16
FUJIFILM Healthcare Americas Corporation16
Konica Minolta, Inc.14
Vieworks Co., Ltd.14
Konica Minolta Medical & Graphic, Inc.13
Canon, Inc.12

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 122 companies shown, in name order