Flat Panel Detector
FDA 510(k) K111824 · Canon Inc. -Medical Equipment Group
510(k) numberK111824
Submission
- Device name
- Flat Panel Detector
- Applicant
- Canon Inc. -Medical Equipment Group
Richardson, TX, US - Received
- June 28, 2011
- Decision date
- April 23, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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
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| K173689 | Ophthalmic Software Platform RXNFJ · Traditional | 02/23/2018SE |
| K162909 | CSX-30 Flat Panel DetectorMQB · Traditional | 01/27/2017SE |
| K123208 | Digital Retinal CameraHKI · Traditional | 03/19/2013SE |
| K121303 | Mobile C-ArmOXO · Traditional | 07/26/2012SE |
| K111710 | Full Auto Tonometer Model TX-20HKX · Special | 09/20/2011SE |
| K112309 | Digital RadiographyMQB · Special | 09/02/2011SE |
| K111682 | Digital RadiographyMQB · Special | 09/02/2011SE |
| K103591 | Digital RadiographyMQB · Special | 03/29/2011SE |
| K102013 | Digital Retinal CameraHKI · Special | 10/29/2010SE |
| K102012 | Digital RadiographyMQB · Special | 08/17/2010SE |
Questions and answers
When was Flat Panel Detector cleared by the FDA?
Flat Panel Detector (K111824) received a 510(k) decision of Substantially Equivalent on April 23, 2012, 300 days after the submission was received.
What is the product code of K111824?
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.