Product code MQB
- Device name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1680
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | 2025-10-09 |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2025-07-22 |
| K250665 | SKR 3000 | Konica Minolta, Inc. | 2025-06-17 |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2025-04-18 |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | 2025-03-20 |
| 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 |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | 2025-03-18 |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. | 2025-02-24 |
| K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2024-12-19 |
| K241319 | SKR 3000 | Konica Minolta, Inc. | 2024-11-21 |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | 2024-11-15 |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | 2024-11-12 |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. | 2024-11-07 |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | 2024-09-09 |
| K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | 2024-03-07 |
| K232082 | EXPD 4343S | DRTECH Corporation | 2024-02-13 |
| K232753 | EXPD 4343D; EXPD 3643D | DRTECH Corporation | 2023-11-16 |
| K230918 | MasterX 800 Series | Medicatech USA | 2023-09-01 |
| K232058 | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | 2023-08-03 |
| K231959 | EXPD 4357; EXPD 4357P | DRTECH Corporation | 2023-08-01 |
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Radmedix, LLC | 2023-07-12 |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Rayence Co., Ltd. | 2023-06-21 |
| K223930 | A1417MCW/A1717MCW/F1417MCW | H&abyz Co., Ltd. | 2023-03-06 |
| K230175 | Digital Radiography CXDI-CS01 | Canon, Inc. | 2023-02-15 |
| K230059 | Digital Flat Panel Detector | Ray Imaging Technology (Haining) Limited | 2023-02-03 |
| K223546 | 14HQ721G-B | Lg Electronics.Inc | 2023-01-27 |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | Careray Digital Medical Technology Co., Ltd. | 2022-12-30 |
| K223009 | Wireless/Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2022-11-27 |
| K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG | DRTECH Corporation | 2022-11-18 |
| K223267 | SKR 3000 | Konica Minolta, Inc. | 2022-11-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08055186671089 | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL | 2026-04-02 |
| 07899581344695 | EVOLVE SENSOR | Alliage S/A Indústrias Médico Odontológica | 2023-12-08 |
| 07899581344701 | EVOLVE SENSOR | Alliage S/A Indústrias Médico Odontológica | 2023-12-08 |
| 07899581340260 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 07899581340277 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 07899581340284 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 07899581340697 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 07899581340727 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 07899581340253 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 08056600520051 | Nical Flat Panel | NICAL SPA | 2023-10-09 |
| 08054890480109 | Discovery RF180 | GENERAL MEDICAL MERATE SPA | 2018-07-11 |
| 08054890480055 | CLISIS SYSTEMS | GENERAL MEDICAL MERATE SPA | 2018-07-11 |
| 08436046001893 | SEDECAL | SEDECAL | 2018-02-15 |
| 08436046001886 | SEDECAL | SEDECAL | 2018-02-15 |
| 08436046002135 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046002128 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046002050 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001916 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001862 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001176 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001497 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001503 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001510 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001527 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001466 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001121 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001114 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046001091 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046000964 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046000940 | SEDECAL | SEDECAL | 2016-10-28 |