Submission Details
| 510(k) Number | K251370 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 02, 2025 |
| Decision Date | December 01, 2025 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Cartesion Prime (PCD-1000A/3) V10.21
Dec 2025
Decision
213d
Days
Class 2
Risk
About This 510(k) Submission
K251370 is an FDA 510(k) clearance for the Cartesion Prime (PCD-1000A/3) V10.21, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on December 1, 2025, 213 days after receiving the submission on May 2, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.
Device Classification
| Product Code | KPS — System, Tomography, Computed, Emission |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1200 |
Manufacturer
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