FDA product code · Radiology
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
Product code MQB covers Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II device regulated under 21 CFR 892.1680. FDA has cleared 423 devices in this code, 3 of them in the last 12 months. Median review time across the 423 most recent decisions is 56 days. openFDA lists 195 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1680
- Review panel
- Radiology
- Clearances
- 423
What is happening in MQB right now?
MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)) has two findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2354-2026, Z-0465-2026). The code is crowded, scoring 64 of 100 — 118 companies hold a clearance here and 3 arrived in the last 12 months (MQB:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2354-2026, Z-0465-2026 |
| Crowding | Context | MQB:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in MQB?
FDA has cleared 423 devices under product code MQB since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260820 | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | |
| K252996 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | |
| K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | |
| K250665 | SKR 3000 | Konica Minolta, Inc. | |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation | |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. |
How long does FDA review take for MQB?
The median FDA review time for MQB is 56 days, measured across the 423 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MQB?
openFDA lists 195 recall records against product code MQB. A recall record covers one firm's corrective action and may span many device lots.
Z-2354-2026Open, ClassifiedPhilips North America LLC
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Z-0465-2026Open, ClassifiedPhilips Medical Systems DMC GmbH
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Z-2042-2023Open, ClassifiedPhilips North America LLC
There is a software login in issue that may prevent the user from logging in.
Z-0239-2022Open, ClassifiedPhilips Healthcare Inc.
The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
Z-1992-2021TerminatedLIEBEL-FLARSHEIM COMPANY LLC
Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
Showing the 5 most recently initiated of 195. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MQB?
MAUDE holds 278 adverse-event reports naming product code MQB, 55 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MQB unusual?
One month sits above MQB's own expected range: 1 March 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 9 | 1–16 | Within expected (1–16) | |
| 9 | 2–14 | Within expected (2–14) | |
| 17 | 3–15 | Above expected (3–15) | |
| 13 | 4–20 | Within expected (4–20) | |
| 11 | 4–19 | Within expected (4–19) | |
| 9 | 5–19 | Within expected (5–19) | |
| 16 | 8–27 | Within expected (8–27) | |
| 7 | 6–20 | Within expected (6–20) | |
| 7 | 4–19 | Within expected (4–19) | |
| 9 | 2–18 | Within expected (2–18) | |
| 14 | 1–16 | Within expected (1–16) | |
| 16 | 3–20 | Within expected (3–20) | |
| 1 | 5–24 | Below expected (5–24) | |
| 2 | 0–19 | Within expected (0–19) | |
| 1 | 0–21 | Within expected (0–21) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in MQB.
What are the predicate devices in MQB?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MQB?
Across the 423 most recent decisions, these applicants filed most often in MQB.
| Applicant | Recent clearances |
|---|---|
| Rayence Co., Ltd. | 28 |
| Canon, Inc. | 27 |
| Iray Technology Taicang , Ltd. | 17 |
| DRTECH Corporation | 14 |
| Vieworks Co., Ltd. | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in MQB file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| DRTECH Corporation | 18 | 2 |
| Carestream Health, Inc. | 15 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MQB
Get an email the morning anything changes in MQB — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.