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FDA 510(k)

Celesteion, PCA-9000A/3, V6.5

K-Number: K181646 · 2018-11-16

ApplicantCanon Medical Systems Corporation
Decision Date2018-11-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Celesteion, PCA-9000A/3, V6.5 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2018-11-16 under approval number K181646. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celesteion, PCA-9000A/3, V6.5?

Celesteion, PCA-9000A/3, V6.5 is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K181646.

When was Celesteion, PCA-9000A/3, V6.5 approved by the FDA?

Celesteion, PCA-9000A/3, V6.5 received FDA 510(k) clearance on 2018-11-16, under approval number K181646.

What company makes Celesteion, PCA-9000A/3, V6.5?

Celesteion, PCA-9000A/3, V6.5 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Celesteion, PCA-9000A/3, V6.5?

The FDA product code for Celesteion, PCA-9000A/3, V6.5 is JAK.

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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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