Cartesion Prime (PCD-1000A/3) V10.21— 510(k) K251370
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K251370 for Cartesion Prime (PCD-1000A/3) V10.21, Substantially Equivalent on 2025-12-01. Applicant: Canon Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Canon Medical Systems Corporation
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
Recent devices under product code KPS
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Data sourced from openFDA. This site is unofficial and independent of the FDA.