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FDA 510(k)

Cartesion Prime, PCD-1000A, V10.7

K-Number: K202349 · 2020-10-15

ApplicantCanon Medical Systems Corporation
Decision Date2020-10-15
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cartesion Prime, PCD-1000A, V10.7 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2020-10-15 under approval number K202349. 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, V10.7?

Cartesion Prime, PCD-1000A, V10.7 is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K202349.

When was Cartesion Prime, PCD-1000A, V10.7 approved by the FDA?

Cartesion Prime, PCD-1000A, V10.7 received FDA 510(k) clearance on 2020-10-15, under approval number K202349.

What company makes Cartesion Prime, PCD-1000A, V10.7?

Cartesion Prime, PCD-1000A, V10.7 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Cartesion Prime, PCD-1000A, V10.7?

The FDA product code for Cartesion Prime, PCD-1000A, V10.7 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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