ClearVision ExamVue Flat Panel Detector
FDA 510(k) K160143 · Jpi Healthcare, Inc.
510(k) numberK160143
Submission
- Device name
- ClearVision ExamVue Flat Panel Detector
- Applicant
- Jpi Healthcare, Inc.
Kuro 3-Dong, Kuro_Gu, KR - Received
- January 21, 2016
- Decision date
- October 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252996 | Universal 1417PIMQB · Abbreviated | Konica Minolta Healthcare Americas, Inc. | 06/12/2026SE |
| 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 |
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| 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 |
More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K260482 | DRE DuoKPR · Traditional | 06/15/2026SE |
| K244010 | ExamVue ApexMQB · Traditional | 02/24/2025SE |
| K213057 | ExamVue DuoKPR · Traditional | 02/18/2022SE |
| K142930 | Exam Vue DRKPR · Traditional | 04/17/2015SE |
| K102327 | Clearvision DR 7000FMQB · Traditional | 04/13/2012SE |
| K101779 | Clearvision DR 2000 Digital Radiography X-Ray SystemKPR · Traditional | 05/16/2011SE |
| K955706 | Jpi Automatic X-Ray Film ProcessorIXW · Traditional | 02/12/1996SE |
| K954161 | Jpi Intensifying ScreenEAM · Traditional | 02/02/1996SE |
| K950043 | Jpi Automatic X-Ray Film ProcessorIXW · Traditional | 05/10/1995SE |
Questions and answers
When was ClearVision ExamVue Flat Panel Detector cleared by the FDA?
ClearVision ExamVue Flat Panel Detector (K160143) received a 510(k) decision of Substantially Equivalent on October 28, 2016, 281 days after the submission was received.
What is the product code of K160143?
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.