FDR D-Evo II Flat Panel Detector System
FDA 510(k) K142003 · Fujifilm Medical System U.S.A., Inc.
510(k) numberK142003
Submission
- Device name
- FDR D-Evo II Flat Panel Detector System
- Applicant
- Fujifilm Medical System U.S.A., Inc.
Stamford, CT, US - Received
- July 23, 2014
- Decision date
- October 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
| K250211 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 07/22/2025SE |
| K250665 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 06/17/2025SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | DRTECH Corporation | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | DRTECH Corporation | 03/19/2025SE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
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| K152138 | FDR D-EVO GL Flat Panel Detector SystemMQB · Traditional | 11/05/2015SE |
| K150221 | EPX-4440HD and EPX-4400HD with FICEFET · Traditional | 10/01/2015SE |
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| K133976 | Fujifilm Endoscopic CO2 RegulatorFCX · Traditional | 09/09/2014SE |
| K132188 | Mammography Viewer SMV658LLZ · Traditional | 10/25/2013SE |
| K130542 | Synapse 3D Lung and Abdomen AnalysisLLZ · Traditional | 06/14/2013SE |
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Questions and answers
When was FDR D-Evo II Flat Panel Detector System cleared by the FDA?
FDR D-Evo II Flat Panel Detector System (K142003) received a 510(k) decision of Substantially Equivalent on October 21, 2014, 90 days after the submission was received.
What is the product code of K142003?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.