ImageSPECTRUM
by Canon Inc.
510(k) K201273
ImageSPECTRUM is a Class II device made by Canon Inc., cleared under FDA 510(k) K201273 on 25 Sep 2020, 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 | NumberK201273 | Date25 Sep 2020 | StatusActive |
Official records
- FDA 510(k) database K201273
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NFJ
- FDA applicant
- Canon, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K201273
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| CANON INC. imageSPECTRUM | imageSPECTRUM | 04549292182729 | — | On the market |
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