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FDA 510(k)

Cartesion Prime (PCD-1000A/3) V10.21

K-Number: K251370 · 2025-12-01

ApplicantCanon Medical Systems Corporation
Decision Date2025-12-01
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cartesion Prime (PCD-1000A/3) V10.21 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2025-12-01 under approval number K251370. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cartesion Prime (PCD-1000A/3) V10.21?

Cartesion Prime (PCD-1000A/3) V10.21 is a medical device that received FDA 510(k) clearance on 2025-12-01. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K251370.

When was Cartesion Prime (PCD-1000A/3) V10.21 approved by the FDA?

Cartesion Prime (PCD-1000A/3) V10.21 received FDA 510(k) clearance on 2025-12-01, under approval number K251370.

What company makes Cartesion Prime (PCD-1000A/3) V10.21?

Cartesion Prime (PCD-1000A/3) V10.21 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Cartesion Prime (PCD-1000A/3) V10.21?

The FDA product code for Cartesion Prime (PCD-1000A/3) V10.21 is KPS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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