Cartesion Prime— 510(k) K191582
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K191582 for Cartesion Prime, Substantially Equivalent on 2019-08-13. 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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- K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
- K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
Data sourced from openFDA. This site is unofficial and independent of the FDA.