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FDA 510(k)

Cartesion Prime (PCD-1000A/3) V10.8

K-Number: K203314 · 2021-04-23

ApplicantCanon Medical Systems Corporation
Decision Date2021-04-23
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cartesion Prime (PCD-1000A/3) V10.8 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2021-04-23 under approval number K203314. 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) V10.8?

Cartesion Prime (PCD-1000A/3) V10.8 is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K203314.

When was Cartesion Prime (PCD-1000A/3) V10.8 approved by the FDA?

Cartesion Prime (PCD-1000A/3) V10.8 received FDA 510(k) clearance on 2021-04-23, under approval number K203314.

What company makes Cartesion Prime (PCD-1000A/3) V10.8?

Cartesion Prime (PCD-1000A/3) V10.8 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Cartesion Prime (PCD-1000A/3) V10.8?

The FDA product code for Cartesion Prime (PCD-1000A/3) V10.8 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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