Intelligent NR
510(k)K212269RadiologyMQB
Canon Inc. is listed for Intelligent NR (K212269). The FDA list gives September 17, 2021 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MQB. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212269
- Date of final decision
- September 17, 2021
- Company on the FDA list
- Canon Inc.
- Lead panel
- Radiology
- Primary product code
- MQB
- openFDA device name for the code
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device class
- 2
- Regulation number
- 892.1680
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary