Digital Flat Panel X-Ray DETECTOR/1210SGA
FDA 510(k) K113630 · Rayence Co., Ltd.
510(k) numberK113630
Submission
- Device name
- Digital Flat Panel X-Ray DETECTOR/1210SGA
- Applicant
- Rayence Co., Ltd.
Houston, TX, US - Received
- December 8, 2011
- Decision date
- December 29, 2011
- 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 |
|---|---|---|
| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | 07/31/2026SE |
| K243849 | 2430TCA with Xmaru WMUE · Special | 03/12/2025SE |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)MQB · Traditional | 09/09/2024SE |
| K240371 | 0909FCC, 0909FCC-HSMQB · Special | 03/07/2024SE |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFMQB · Special | 06/21/2023SE |
| K220689 | Vatech ClismileNJM · Traditional | 05/06/2022SE |
| K212753 | 0909FCB, 1212FCAMQB · Special | 10/18/2021SE |
| K202902 | 2430MCA with Xmaru WMUE · Traditional | 06/21/2021SE |
| K210985 | 1717FCCMQB · Special | 04/28/2021SE |
| K202722 | 1212FCAMQB · Special | 10/26/2020SE |
Questions and answers
When was Digital Flat Panel X-Ray DETECTOR/1210SGA cleared by the FDA?
Digital Flat Panel X-Ray DETECTOR/1210SGA (K113630) received a 510(k) decision of Substantially Equivalent on December 29, 2011, 21 days after the submission was received.
What is the product code of K113630?
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.