Digital Radiography
FDA 510(k) K112309 · Canon Inc. -Medical Equipment Group
510(k) numberK112309
Submission
- Device name
- Digital Radiography
- Applicant
- Canon Inc. -Medical Equipment Group
Tachikawa-Shi, Tokyo, JP - Received
- August 11, 2011
- Decision date
- September 2, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K111824 | Flat Panel DetectorMQB · Traditional | 04/23/2012SE |
| K111710 | Full Auto Tonometer Model TX-20HKX · Special | 09/20/2011SE |
| 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 Digital Radiography cleared by the FDA?
Digital Radiography (K112309) received a 510(k) decision of Substantially Equivalent on September 2, 2011, 22 days after the submission was received.
What is the product code of K112309?
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.