ImageSPECTRUM— 510(k) K201273
Substantially EquivalentCanon, Inc.
FDA 510(k) clearance K201273 for ImageSPECTRUM, Substantially Equivalent on 2020-09-25. Applicant: Canon, Inc.. Device class: 2.
Clearance details
- Applicant
- Canon, Inc.
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nakahara-Ku, Kawasaki, JP
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