Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation 892.1680
3510(k)s in 12 months (424 all time)
2recalls in 12 months (195 all time)
193recalls that name a 510(k)
Top companies in MQB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K253800 | 0909FCE, 0909FCE-HS Rayence Co., Ltd., KR | MQB |
| Jun 18, 2026 | K260820 | VIVIX-S 4386W (FXRD-4386WA) Vieworks Co., Ltd., KR | MQB |
| Jun 12, 2026 | K252996 | Universal 1417PI Konica Minolta Healthcare Americas, Inc. | MQB |
| Oct 9, 2025 | K252911 | Lux HD 2530 detector (Lux HD 2530) Iray Imaging Technology (Haining) Limited, CN | MQB |
| Jul 22, 2025 | K250211 | Yushan X-Ray Flat Panel Detector Innocare Optoelectronics Corp., TW | MQB |
| Jun 17, 2025 | K250665 | SKR 3000 Konica Minolta, Inc., JP | MQB |
| Apr 18, 2025 | K243734 | Wireless/ Wired X-Ray Flat Panel Detectors Allengers Medical Systems Limited, IN | MQB |
| Mar 20, 2025 | K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG DRTECH Corporation, KR | MQB |
| Mar 19, 2025 | K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD DRTECH Corporation, KR | MQB |
| Mar 18, 2025 | K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) Iray Imaging Technology (Haining) Limited, CN | MQB |
| Feb 24, 2025 | K244010 | ExamVue Apex Jpi Healthcare Co, Ltd., KR | MQB |
| Dec 19, 2024 | K243171 | Yushan X-Ray Flat Panel Detector Innocare Optoelectronics Corp., TW | MQB |
| Nov 21, 2024 | K241319 | SKR 3000 Konica Minolta, Inc., JP | MQB |
| Nov 15, 2024 | K241125 | VIVIX-S 1751S Vieworks Co., Ltd., KR | MQB |
| Nov 12, 2024 | K240771 | PRORAD X-Ray Flat Panel Detector with DROC Prognosys Medical Systems Private Limited, IN | MQB |
| Nov 7, 2024 | K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) Aspen Imaging Healthcare, Inc. | MQB |
| Sep 9, 2024 | K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) Rayence Co., Ltd., KR | MQB |
| Mar 7, 2024 | K240371 | 0909FCC, 0909FCC-HS Rayence Co., Ltd., KR | MQB |
| Feb 13, 2024 | K232082 | EXPD 4343S DRTECH Corporation, KR | MQB |
| Nov 16, 2023 | K232753 | EXPD 4343D; EXPD 3643D DRTECH Corporation, KR | MQB |
| Sep 1, 2023 | K230918 | MasterX 800 Series Medicatech USA | MQB |
| Aug 3, 2023 | K232058 | YosemiteView 4343W/YosemiteView 3643W Careray Digital Medical Technology Co., Ltd., CN | MQB |
| Aug 1, 2023 | K231959 | EXPD 4357; EXPD 4357P DRTECH Corporation, KR | MQB |
| Jul 12, 2023 | K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 Radmedix, LLC | MQB |
| Jun 21, 2023 | K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF Rayence Co., Ltd., KR | MQB |
| Mar 6, 2023 | K223930 | A1417MCW/A1717MCW/F1417MCW H&abyz Co., Ltd., KR | MQB |
| Feb 15, 2023 | K230175 | Digital Radiography CXDI-CS01 Canon, Inc., JP | MQB |
| Feb 3, 2023 | K230059 | Digital Flat Panel Detector Ray Imaging Technology (Haining) Limited, CN | MQB |
| Jan 27, 2023 | K223546 | 14HQ721G-B Lg Electronics.Inc, KR | MQB |
| Dec 30, 2022 | K223687 | X-ray Flat Panel Detectors (EverestView 4343X) Careray Digital Medical Technology Co., Ltd., CN | MQB |
| Nov 27, 2022 | K223009 | Wireless/Wired X-Ray Flat Panel Detectors Allengers Medical Systems Limited, IN | MQB |
| Nov 18, 2022 | K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG DRTECH Corporation, KR | MQB |
| Nov 17, 2022 | K223267 | SKR 3000 Konica Minolta, Inc., JP | MQB |
| Oct 20, 2022 | K222886 | Mercu 1717V Iray Technology Taicang , Ltd., CN | MQB |
| Oct 17, 2022 | K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 Canon, Inc., JP | MQB |
| Sep 29, 2022 | K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 Canon, Inc., JP | MQB |
| Sep 27, 2022 | K222661 | Digital Radiography CXDI-CS01 Canon, Inc., JP | MQB |
| Sep 13, 2022 | K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) Vieworks Co., Ltd., KR | MQB |
| Aug 1, 2022 | K221549 | X-ray Flat Panel Detectors (CareView 1800 RF) Careray Digital Medical Technology Co., Ltd., CN | MQB |
| Jul 22, 2022 | K221461 | 10HQ701G-B Lg Electronics.Inc, KR | MQB |
| Jul 22, 2022 | K221394 | 14HQ701G-B Lg Electronics.Inc, KR | MQB |
| Jul 20, 2022 | K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) Vieworks Co., Ltd., KR | MQB |
| Jul 15, 2022 | K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 Canon, Inc., JP | MQB |
| Jul 13, 2022 | K221434 | 17HQ701G-B Lg Electronics.Inc, KR | MQB |
| Jun 29, 2022 | K221714 | Flat Panel Detector Iray Technology Taicang , Ltd., CN | MQB |
| Jun 16, 2022 | K221345 | Wireless Digital Flat Panel Detector Iray Technology Taicang , Ltd., CN | MQB |
| Jun 14, 2022 | K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 Canon, Inc., JP | MQB |
| May 13, 2022 | K221144 | PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG Radisen Co., Ltd., KR | MQB |
| May 5, 2022 | K220559 | 17HQ901G-B Lg Electronics.Inc, KR | MQB |
| Apr 28, 2022 | K220536 | Digital flat panel detector Iray Technology Taicang , Ltd., CN | MQB |
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