Intelligent NR
510(k) K212269
Intelligent NR is a Class II device made by Canon Inc., cleared under FDA 510(k) K212269 on 17 Sep 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212269 | Date17 Sep 2021 | StatusActive |
Official records
- FDA 510(k) database K212269
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQB
- FDA applicant
- Canon, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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