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FDA 510(k)

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A

K-Number: K182223 · 2018-09-14

ApplicantCanon Medical Systems, USA
Decision Date2018-09-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is a medical device manufactured by Canon Medical Systems, USA. It received FDA 510(k) clearance on 2018-09-14 under approval number K182223. 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 Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Canon Medical Systems, USA. The 510(k) number is K182223.

When was Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A approved by the FDA?

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A received FDA 510(k) clearance on 2018-09-14, under approval number K182223.

What company makes Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A is manufactured by Canon Medical Systems, USA.

What is the FDA product code for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A?

The FDA product code for Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A 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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