← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
DEVICE CLASS
Class II
REGULATION
21 CFR 892.1680
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
15
510(K)/PMA CLEARANCES
510k: 15
0
RECALL ENTRIES
Recent clearances
K260820Vieworks Co., Ltd. · 510k2026-06-18
K252996Konica Minolta Healthcare Americas, Inc. · 510k2026-06-12
K252911Iray Imaging Technology (Haining) Limited · 510k2025-10-09
K250211Innocare Optoelectronics Corp. · 510k2025-07-22
K250665Konica Minolta, Inc. · 510k2025-06-17
K243734Allengers Medical Systems Limited · 510k2025-04-18
K242770DRTECH Corporation · 510k2025-03-20
K243443DRTECH Corporation · 510k2025-03-19
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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