Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MQB — Predicate Candidate Screening
424 FDA 510(k) clearances under this product code; the 50 most recent screened below.
56 daysmedian FDA review time
179 days90th percentile
424clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | 2026-07-31 | 245 | 0 |
| K260820 | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | 2026-06-18 | 97 | 0 |
| K252996 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | 2026-06-12 | 267 | 0 |
| K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | 2025-10-09 | 27 | 0 |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2025-07-22 | 179 | 0 |
| K250665 | SKR 3000 | Konica Minolta, Inc. | 2025-06-17 | 104 | 0 |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2025-04-18 | 135 | 0 |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | 2025-03-20 | 188 | 0 |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343 | DRTECH Corporation | 2025-03-19 | 133 | 0 |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 4 | Iray Imaging Technology (Haining) Limited | 2025-03-18 | 120 | 0 |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. | 2025-02-24 | 60 | 0 |
| K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2024-12-19 | 80 | 0 |
| K241319 | SKR 3000 | Konica Minolta, Inc. | 2024-11-21 | 195 | 0 |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | 2024-11-15 | 206 | 0 |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | 2024-11-12 | 236 | 0 |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray | Aspen Imaging Healthcare, Inc. | 2024-11-07 | 178 | 0 |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717 | Rayence Co., Ltd. | 2024-09-09 | 27 | 0 |
| K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | 2024-03-07 | 29 | 0 |
| K232082 | EXPD 4343S | DRTECH Corporation | 2024-02-13 | 215 | 0 |
| K232753 | EXPD 4343D; EXPD 3643D | DRTECH Corporation | 2023-11-16 | 69 | 0 |
| K230918 | MasterX 800 Series | Medicatech USA | 2023-09-01 | 151 | 0 |
| K232058 | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | 2023-08-03 | 23 | 0 |
| K231959 | EXPD 4357; EXPD 4357P | DRTECH Corporation | 2023-08-01 | 29 | 0 |
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Radmedix, LLC | 2023-07-12 | 30 | 0 |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Rayence Co., Ltd. | 2023-06-21 | 30 | 0 |
| K223930 | A1417MCW/A1717MCW/F1417MCW | H&abyz Co., Ltd. | 2023-03-06 | 66 | 0 |
| K230175 | Digital Radiography CXDI-CS01 | Canon, Inc. | 2023-02-15 | 26 | 0 |
| K230059 | Digital Flat Panel Detector | Ray Imaging Technology (Haining) Limited | 2023-02-03 | 25 | 0 |
| K223546 | 14HQ721G-B | Lg Electronics.Inc | 2023-01-27 | 63 | 0 |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | Careray Digital Medical Technology Co., Ltd. | 2022-12-30 | 21 | 0 |
| K223009 | Wireless/Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2022-11-27 | 59 | 0 |
| K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG | DRTECH Corporation | 2022-11-18 | 46 | 0 |
| K223267 | SKR 3000 | Konica Minolta, Inc. | 2022-11-17 | 24 | 0 |
| K222886 | Mercu 1717V | Iray Technology Taicang , Ltd. | 2022-10-20 | 27 | 0 |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | 2022-10-17 | 26 | 0 |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | 2022-09-29 | 23 | 0 |
| K222661 | Digital Radiography CXDI-CS01 | Canon, Inc. | 2022-09-27 | 25 | 0 |
| K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | Vieworks Co., Ltd. | 2022-09-13 | 228 | 0 |
| K221549 | X-ray Flat Panel Detectors (CareView 1800 RF) | Careray Digital Medical Technology Co., Ltd. | 2022-08-01 | 62 | 0 |
| K221461 | 10HQ701G-B | Lg Electronics.Inc | 2022-07-22 | 64 | 0 |
| K221394 | 14HQ701G-B | Lg Electronics.Inc | 2022-07-22 | 70 | 0 |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Vieworks Co., Ltd. | 2022-07-20 | 57 | 0 |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | 2022-07-15 | 17 | 0 |
| K221434 | 17HQ701G-B | Lg Electronics.Inc | 2022-07-13 | 57 | 0 |
| K221714 | Flat Panel Detector | Iray Technology Taicang , Ltd. | 2022-06-29 | 16 | 0 |
| K221345 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2022-06-16 | 38 | 0 |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | 2022-06-14 | 11 | 0 |
| K221144 | PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG | Radisen Co., Ltd. | 2022-05-13 | 23 | 0 |
| K220559 | 17HQ901G-B | Lg Electronics.Inc | 2022-05-05 | 66 | 0 |
| K220536 | Digital flat panel detector | Iray Technology Taicang , Ltd. | 2022-04-28 | 63 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda