Digital flat panel detector
FDA 510(k) K220536 · Iray Technology Taicang , Ltd.
510(k) numberK220536
Submission
- Device name
- Digital flat panel detector
- Applicant
- Iray Technology Taicang , Ltd.
Taicang, CN - Received
- February 24, 2022
- Decision date
- April 28, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K223010 | Portable X-ray SystemEHD · Traditional | 01/17/2023SE |
| K222886 | Mercu 1717VMQB · Special | 10/20/2022SE |
| K221714 | Flat Panel DetectorMQB · Special | 06/29/2022SE |
| K221345 | Wireless Digital Flat Panel DetectorMQB · Special | 06/16/2022SE |
| K220668 | Wireless Digital Flat Panel DetectorMQB · Special | 04/01/2022SE |
| K213646 | Focus HD 35 DetectorMQB · Special | 03/29/2022SE |
| K213529 | Focus HD 43 DetectorMQB · Special | 03/29/2022SE |
| K220422 | Dental sensors NanoPix1, NanoPix2MUH · Special | 03/11/2022SE |
| K212279 | Digital Intraoral X-ray Imaging SystemMUH · Traditional | 10/07/2021SE |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging SystemMUH · Traditional | 04/23/2021SE |
Questions and answers
When was Digital flat panel detector cleared by the FDA?
Digital flat panel detector (K220536) received a 510(k) decision of Substantially Equivalent on April 28, 2022, 63 days after the submission was received.
What is the product code of K220536?
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.