X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
FDA 510(k) K201932 · Careray Digital Medical System Co., Ltd.
510(k) numberK201932
Submission
- Device name
- X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
- Applicant
- Careray Digital Medical System Co., Ltd.
Suzhou, CN - Received
- July 13, 2020
- Decision date
- August 7, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MQB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | Rayence Co., Ltd. | 07/31/2026SE |
| K260820 | Vivix-S 4386W (FXRD-4386WA)MQB · Special | Vieworks Co., Ltd. | 06/18/2026SE |
| 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 |
| 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 |
More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K202995 | X-ray Flat Panel Detectors/CareView 3600RFMQB · Traditional | 02/19/2021SE |
| K193173 | CareView 1800LeMQB · Special | 12/13/2019SE |
| K172581 | CareView 1800Cw X-ray Flat Panel DetectorsMQB · Special | 09/26/2017SE |
| K163019 | CareView 750Cw/750C X-ray Flat Panel DetectorsMQB · Special | 12/01/2016SE |
| K162178 | CareView 1500P X-ray Flat Panel DetectorsMQB · Special | 09/01/2016SE |
| K153492 | CareView 1800LMQB · Special | 12/24/2015SE |
| K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsMQB · Special | 11/10/2015SE |
| K141488 | Careview 1800RMQB · Traditional | 09/08/2015SE |
| K150929 | CareView 1500Cw X-ray Flat Panel DetectorsMQB · Traditional | 08/04/2015SE |
Questions and answers
When was X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) cleared by the FDA?
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) (K201932) received a 510(k) decision of Substantially Equivalent on August 7, 2020, 25 days after the submission was received.
What is the product code of K201932?
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.