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FDA 510(k)

CT Scanner TSX-501R/1 V11.1

K-Number: K243398 · 2025-06-20

ApplicantCanon Medical Systems Corporation
Decision Date2025-06-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT Scanner TSX-501R/1 V11.1 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2025-06-20 under approval number K243398. 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 CT Scanner TSX-501R/1 V11.1?

CT Scanner TSX-501R/1 V11.1 is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K243398.

When was CT Scanner TSX-501R/1 V11.1 approved by the FDA?

CT Scanner TSX-501R/1 V11.1 received FDA 510(k) clearance on 2025-06-20, under approval number K243398.

What company makes CT Scanner TSX-501R/1 V11.1?

CT Scanner TSX-501R/1 V11.1 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for CT Scanner TSX-501R/1 V11.1?

The FDA product code for CT Scanner TSX-501R/1 V11.1 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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