FDA Product Code
FDA Product Code MQB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1680
510(k) Clearances — 424 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | 2026-07-31 | Traditional | PDF ↗ |
| K260820 | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | 2026-06-18 | Special | PDF ↗ |
| K252996 | Universal 1417PI | Konica Minolta Healthcare Americas, Inc. | 2026-06-12 | Abbreviated | PDF ↗ |
| K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | 2025-10-09 | Special | PDF ↗ |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2025-07-22 | Traditional | PDF ↗ |
| K250665 | SKR 3000 | Konica Minolta, Inc. | 2025-06-17 | Traditional | PDF ↗ |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2025-04-18 | Special | PDF ↗ |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | 2025-03-20 | Special | PDF ↗ |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation | 2025-03-19 | Special | PDF ↗ |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | 2025-03-18 | Traditional | PDF ↗ |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. | 2025-02-24 | Traditional | PDF ↗ |
| K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2024-12-19 | Traditional | PDF ↗ |
| K241319 | SKR 3000 | Konica Minolta, Inc. | 2024-11-21 | Traditional | PDF ↗ |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | 2024-11-15 | Traditional | PDF ↗ |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | 2024-11-12 | Traditional | PDF ↗ |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. | 2024-11-07 | Traditional | PDF ↗ |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | 2024-09-09 | Traditional | PDF ↗ |
| K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | 2024-03-07 | Special | PDF ↗ |
| K232082 | EXPD 4343S | DRTECH Corporation | 2024-02-13 | Special | PDF ↗ |
| K232753 | EXPD 4343D; EXPD 3643D | DRTECH Corporation | 2023-11-16 | Special | PDF ↗ |
| K230918 | MasterX 800 Series | Medicatech USA | 2023-09-01 | Traditional | PDF ↗ |
| K232058 | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | 2023-08-03 | Special | PDF ↗ |
| K231959 | EXPD 4357; EXPD 4357P | DRTECH Corporation | 2023-08-01 | Special | PDF ↗ |
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Radmedix, LLC | 2023-07-12 | Traditional | PDF ↗ |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Rayence Co., Ltd. | 2023-06-21 | Special | PDF ↗ |
| K223930 | A1417MCW/A1717MCW/F1417MCW | H&abyz Co., Ltd. | 2023-03-06 | Traditional | PDF ↗ |
| K230175 | Digital Radiography CXDI-CS01 | Canon, Inc. | 2023-02-15 | Special | PDF ↗ |
| K230059 | Digital Flat Panel Detector | Ray Imaging Technology (Haining) Limited | 2023-02-03 | Special | PDF ↗ |
| K223546 | 14HQ721G-B | Lg Electronics.Inc | 2023-01-27 | Traditional | PDF ↗ |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | Careray Digital Medical Technology Co., Ltd. | 2022-12-30 | Special | PDF ↗ |
| K223009 | Wireless/Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2022-11-27 | Traditional | PDF ↗ |
| K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG | DRTECH Corporation | 2022-11-18 | Special | PDF ↗ |
| K223267 | SKR 3000 | Konica Minolta, Inc. | 2022-11-17 | Special | PDF ↗ |
| K222886 | Mercu 1717V | Iray Technology Taicang , Ltd. | 2022-10-20 | Special | PDF ↗ |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | 2022-10-17 | Special | PDF ↗ |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | 2022-09-29 | Special | PDF ↗ |
| K222661 | Digital Radiography CXDI-CS01 | Canon, Inc. | 2022-09-27 | Special | PDF ↗ |
| K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | Vieworks Co., Ltd. | 2022-09-13 | Traditional | PDF ↗ |
| K221549 | X-ray Flat Panel Detectors (CareView 1800 RF) | Careray Digital Medical Technology Co., Ltd. | 2022-08-01 | Traditional | PDF ↗ |
| K221461 | 10HQ701G-B | Lg Electronics.Inc | 2022-07-22 | Traditional | PDF ↗ |
| K221394 | 14HQ701G-B | Lg Electronics.Inc | 2022-07-22 | Traditional | PDF ↗ |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Vieworks Co., Ltd. | 2022-07-20 | Traditional | PDF ↗ |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | 2022-07-15 | Special | PDF ↗ |
| K221434 | 17HQ701G-B | Lg Electronics.Inc | 2022-07-13 | Traditional | PDF ↗ |
| K221714 | Flat Panel Detector | Iray Technology Taicang , Ltd. | 2022-06-29 | Special | PDF ↗ |
| K221345 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2022-06-16 | Special | PDF ↗ |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | 2022-06-14 | Special | PDF ↗ |
| K221144 | PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG | Radisen Co., Ltd. | 2022-05-13 | Special | PDF ↗ |
| K220559 | 17HQ901G-B | Lg Electronics.Inc | 2022-05-05 | Traditional | PDF ↗ |
| K220536 | Digital flat panel detector | Iray Technology Taicang , Ltd. | 2022-04-28 | Traditional | PDF ↗ |
| K220510 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2022-04-14 | Traditional | PDF ↗ |
| K220668 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2022-04-01 | Special | PDF ↗ |
| K213646 | Focus HD 35 Detector | Iray Technology Taicang , Ltd. | 2022-03-29 | Special | PDF ↗ |
| K213529 | Focus HD 43 Detector | Iray Technology Taicang , Ltd. | 2022-03-29 | Special | PDF ↗ |
| K214044 | 14HQ901G-B | Lg Electronics.Inc | 2022-02-16 | Traditional | PDF ↗ |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | 2022-02-04 | Special | PDF ↗ |
| K213908 | SKR 3000 | Konica Minolta, Inc. | 2022-01-31 | Traditional | PDF ↗ |
| K213780 | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 | Canon, Inc. | 2022-01-24 | Traditional | PDF ↗ |
| K214030 | Universal DR 1748 | Konica Minolta Healthcare Americas, Inc. | 2022-01-21 | Traditional | PDF ↗ |
| K213307 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | 2022-01-14 | Traditional | PDF ↗ |
| K213469 | VALORY | Agfa N.V. | 2021-11-18 | Traditional | PDF ↗ |
| K213497 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | H&abyz Co., Ltd. | 2021-11-15 | Special | PDF ↗ |
| K212753 | 0909FCB, 1212FCA | Rayence Co., Ltd. | 2021-10-18 | Special | PDF ↗ |
| K212269 | Intelligent NR | Canon, Inc. | 2021-09-17 | Traditional | PDF ↗ |
| K212553 | DIGITAL RADIOGRAPHY CXDI-Pro, D1 | Canon, Inc. | 2021-09-09 | Special | PDF ↗ |
| K212051 | RFA-1717DIG, RFA-1717DIC | Astel, Inc. | 2021-08-25 | Traditional | PDF ↗ |
| K210619 | SKR 3000 | Konica Minolta, Inc. | 2021-08-24 | Traditional | PDF ↗ |
| K212105 | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF | Pzmedical Technology Co., Ltd. | 2021-08-23 | Traditional | PDF ↗ |
| K211790 | DX-D Imaging Package with XD Detectors | Agfa N.V. | 2021-07-30 | Traditional | PDF ↗ |
| K211542 | PRIMO S | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021-07-09 | Traditional | PDF ↗ |
| K211108 | Prudent 1717, Prudent 1417, Prudent 1212 | Pixxgen Corporation | 2021-06-04 | Traditional | PDF ↗ |
| K210919 | AcuityDRe | Radmedix, LLC | 2021-04-30 | Traditional | PDF ↗ |
| K210985 | 1717FCC | Rayence Co., Ltd. | 2021-04-28 | Special | PDF ↗ |
| K210988 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2021-04-21 | Traditional | PDF ↗ |
| K202441 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | 2021-04-02 | Traditional | PDF ↗ |
| K203703 | I-Q View | First Source, Inc. | 2021-03-24 | Traditional | PDF ↗ |
| K203188 | ADD | H&abyz Co., Ltd. | 2021-03-12 | Traditional | PDF ↗ |
| K210316 | Mars 1417X Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2021-03-03 | Special | PDF ↗ |
| K210314 | Mars1717X Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | 2021-03-02 | Special | PDF ↗ |
| K202995 | X-ray Flat Panel Detectors/CareView 3600RF | Careray Digital Medical System Co., Ltd. | 2021-02-19 | Traditional | PDF ↗ |
| K203849 | General Radiography CXDI-CS01 | Canon, Inc. | 2021-01-26 | Special | PDF ↗ |
| K203159 | Lux 35 Detector | Carestream Health | 2020-12-02 | Special | PDF ↗ |
| K202722 | 1212FCA | Rayence Co., Ltd. | 2020-10-26 | Special | PDF ↗ |
| K201528 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2020-10-11 | Traditional | PDF ↗ |
| K202564 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2020-09-30 | Special | PDF ↗ |
| K201591 | Flat Panel Detector | Ka Imaging, Inc. | 2020-09-03 | Traditional | PDF ↗ |
| K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | Careray Digital Medical System Co., Ltd. | 2020-08-07 | Special | PDF ↗ |
| K201796 | 1717SCV, 1717SGV | Rayence Co., Ltd. | 2020-07-23 | Special | PDF ↗ |
| K201503 | Edge Air(1417) Digital Flat Panel X-ray Detector | Osko, Inc. | 2020-06-29 | Special | PDF ↗ |
| K201247 | Intraoral Sensor | Dentium Co., Ltd (Ict Branch) | 2020-06-10 | Traditional | PDF ↗ |
| K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | Iray Technology Taicang , Ltd. | 2020-05-12 | Special | PDF ↗ |
| K201058 | Accuvue+ | Radmedix, LLC | 2020-05-06 | Special | PDF ↗ |
| K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W | Iray Technology Taicang , Ltd. | 2020-05-01 | Special | PDF ↗ |
| K200787 | BSD3543W | Bontech Co., Ltd. | 2020-04-23 | Special | PDF ↗ |
| K200668 | DR-ID 1200SDK System | Fujifilm Corporation | 2020-04-10 | Special | PDF ↗ |
| K200622 | Focus 43C detector, TRIMAX 43C detector | Iray Technology Taicang , Ltd. | 2020-04-01 | Special | PDF ↗ |
| K200418 | VIVIX-S VW | Vieworks Co., Ltd. | 2020-03-18 | Traditional | PDF ↗ |
| K192894 | Vita Flex CR System with LLI | Carestream Health, Inc. | 2020-02-18 | Special | PDF ↗ |
| K193644 | E-COM DR-2000 DR | Livermoretech, Inc. | 2020-02-14 | Traditional | PDF ↗ |
| K200018 | HAD1717MC | H&Abyz | 2020-01-31 | Traditional | PDF ↗ |
Product code MQB · Class II · Radiology. Data: openFDA.